Camelia Rodriguez-Riquelme

CRR
Camelia Rodriguez-Riquelme
Professional Summary Contact Information
CQV expert with more than twenty-five (25) years of experience in the
biopharmaceutical, biotechnology and medical device industries, along
with other private sectors (construction, thermo-electrical power plants, rodriguez_camelia@hotmail.com
engineering firms). Experience in construction, commissioning, validation, 787-356-9930
Startups, quality assurance and compliance related projects. Extensive 3 Glendale Road
experience with controlled documentation generation, development, Sharon, Massachusetts 02061
review, audit and/or execution, and/or approval of SOP, ETP, PMs, URS,
Validation Protocols and Reports, Change Controls, CAPA, Risk
Assessments, Test Documentation, Summary Reports, Quality Policies,
C&Q, Source Documents (Specifications, Functional Tests) and Engineering
Skills
Documentation. Experienced in Commissioning and Qualification for
• CQV (Process Equipment, Facilities,
Utilities (Compressed Air, CO2, O2, Water Systems) and the major Clean
Utilities and Processes)
Suite equipment (Bioreactors, Wash Vessels, Gas Control Modules, Heat
and Cooling Controllers, among others) and critical instrumentations
• Quality Management Systems & Risk
(Calibration Programs, Assets Risk Assessment, Preventive Maintenance).
Management Systems
Also experienced in ensuring that multidisciplinary functional departments
work in unison to reach Corporate's committed goals. She foresees project • IQ/OQ/PQ and Process Validation
scope, budget and schedule challenges in a proactive manner, to minimize
the adverse effect on operational objectives. Coordination, development • Regulatory Compliance (21CFR Part 11,
and monitoring of Commissioning, Qualification and Validation (CQV) 201, 211, 600, 820, ISO 9000/13485, ICH
activities, engineering and process activities, validation efforts and Q7/Q8/Q9/Q10)
compliance projects. Performing commissioning, system start-up, and
ending with the Turn-Over-Packages (TOP). She has generated, developed, • Project Management (C&Q Project
coordinated, supported, executed, and/or led IQ, OQ, PQ, PV and RV Manager, Clinical Trials,
protocols to validate new equipment and/or modifications to existing Commissioning Engineer, Program
systems (upgrading, refurbishment, C&Q, de-commissioning). This Manager)
includes training of personnel. Knowledge of cGMP regulations, 21 CFR
Standards (Part 11, 210, 211, 600, 610 and 820), ISO 9000, ICH Q7A, Q9, Q10, • Software (MS Office, TrackWise,
ISO 13485. Standardizing controlled documentation, ensuring consistency, Livelink, EAMS, LIMS, SharePoint,
accountability and traceability. Auditing compliancy between Corporate, Veeva Vault/CDOCS, Box, RSA,
Site and Facilities. SecurID, DocuSign, Plateau, Enterprise,
Microsoft TEAMs, ZOOM)

Work History • Documentation (System Boundaries,
URS, Design Review Processes,
Engineering Run/Test, FAT/SAT,
Integrated Commissioning & Qualification Consultants (ICQ),
ETOPs, Technical & Functional
Corporation 08/2017 – Present
Specifications, VMP, APR, QM, C&Q
Plan, CARA, CAPA, Investigational
Quality Assurance Validation (QAV) Reports, Deviation Trends, Impact
AMGEN, Building AR05, West Greenwich, RI 10/2019 – 1/2020 Assessments, Data Sheets, Plan
Development Impact Assessments
Primary Responsibilities: Provide Quality Assurance support for the
Capacity Increase Project in the review and approval of Source Documents
(Specifications), Commissioning, Qualification and Validation
documentation, such as Installation/Operational and Performance
Qualification Protocols, Specifications, Supporting multiple Quality
Assurance Team Groups (QA-Validation and QA-Off-The-Floor) in the Personal Traits
review and approval of the following:
• Commissioning and Qualification Plan for the Project
• Presently, willing to work
• Software Configuration Parameters Verification & Functional within the state of
Specification review/approval (DeltaV Control System Action, Massachusetts ONLY
Control Module, Parameter, Graphics and Module Supervisor
Verifications) • Self-Starter with a high level of
• Qualification documentation for Purification Tanks SIP initiative
Configuration, Cleaning Tanks, DeltaV FM Capacity Increase
Phases, Test Requirements for Buffer Operations, Purification • Work, perform, produce and
Transfer Line SIP Configuration, Viral Filtration Buffer Supply CIP obtain objectives and goals for
Decouple the benefit of the Team, not for
personal gain
• Source Documents (DeltaV Control System Specifications
associated to Recipes, Chromatography Skids, Buffer Hold Tanks,
• Presents a high level of
Purification Tanks SIP Configuration, Final UFDF Tank
administrative competence
• Commissioning Documentation (Installation Verifications and
Functional Testing for the Chromatography Skids, Load Tanks, • Policies and procedure
Unload Tanks for SIP Cycles, Downstream Fill Pumps Recipe and development in order to
Formula Parameter Verifications using various Verification Tools improve department/work
• Line Verification (weld documentation, welders review, pressure, force
passivation, dye penetrant, riboflavin, surface roughness, and
drain-ability test reports, among others) associated to Buffer Hold • Projects a positive image
Tanks
• Skillful communicator
• Ensure that all changes performed per approved and executed
(English/Spanish, effective and
change controls are captured in the impacted standard operating
positive intercommunications
procedures (SOPs)
and interactions, translate
complex information into
CQV Senior Consultant common terms, transfers
PFIZER, Andover Clinical Manufacturing Facility 11/2018 – 8/2019 knowledge for the benefit of
the team)
Primary Responsibilities: The development of Validation and Engineering
Documents (generation and/or execution), such as Installation/Operational • Competent performance with a
Qualification Protocols, Engineering Change Management and Non- strong personal effectiveness;
Conformance reports. Supporting multiple Team Groups in the blending management skills
development of the following: with technical expertise
• Generate, develop and execute all validation documentation
• Highly responsible and
required for Facilities (Compressed Air, CO2, O2) and major Clean
accountable for meeting
Suite equipment (Bioreactors, Wash Vessels, Gas Control Modules,
goals/deadlines
Heat and Cooling Controllers, among others)
• Design Specification, Software Configuration Parameters • Reliable, conscientious,
Verification & Functional Specification review punctual and committed, with
• Execution of validation protocols/test plans and document results the highest degree of honesty,
ensuring Good Documentation Practices (GDP) and Good loyalty and integrity
Manufacturing Practices (GMP)
• Provide training in Validation to less experienced team members • Human resource optimization
(career, needs, personal
• Leadership Team with any support needed (strategizing, multi-
growth and training
facetted executions in cGMP and non-cGMP environments)
development, reinforce
• Review and coordinate all Piping Verification with contracting positive behavior and
firms (weld documentation, welders review, pressure, passivation, colleague/employee's strength,
dye penetrant, riboflavin, surface roughness, and drain-ability test encouraging constructive
reports, among others) actions, acknowledging Teams
• Work with suppliers and vendors, ensuring documentation attributes, and facilitating
compliancy for all purchased equipment, skids and/or detailed learning)
items, to ensure ETOPs are complete and accurately contain
installation items • Quality control of most crucial
of variables contributing to the
realization of
Senior Consultant departmental/project goals and
Genzyme-Sanofi, Framingham, MA 08/2017 – 11/2018 objectives
Primary Responsibilities: The development of Validation and Engineering
• Develop, obtain, and manage
Documents (generation and/or execution), such as Installation/Operational
managerial/projects objectives
Qualification Protocols, Engineering Change Management and Non-
Conformance reports. Supporting multiple Team Groups in the • Prioritization of objective in
development of the following: order to meet the Teams goals;
• Trace Matrix, Assessment Management (Spare Parts List for maximizing organizational
Central Inventory, asset identifications for all new components, productivity
Maintenance Operations/Program, Change Control, Vendor Turn
• Work cooperatively toward the
Over Package, drawing verification, asset criticality determination,
identification of areas needing
and PM development.
improvement
• Validation Executions included Wave bioreactors, disposable wave
bags, seed bioreactors, production bioreactors, flasks spinners, • Effective in resolving inter-
shaker bases, wave rocker system, tubing welder & sealer, external departmental conflicts
peristaltic pumps, parts washer's main and sub racks, spray balls
• Facilities and Utilities System Review for Specification compliance • "Simply Getting the Job
gap analysis Done"

Rangam Consulting 02/2016 – 08/2017

Commissioning Engineer IV
Genzyme-Sanofi, Framingham, MA
Primary Responsibilities: Generate, develop and execute the Design
Qualifications and Start-Up for the Systems in the Seed Train Improvement
Project, which include protocols generation, approvals, executions and
reports. Also support in the following:
• New equipment in the Metrology Program (database and
calibration), Preventive Maintenance Program (develop SOP for
PM, Job Plans), Central Inventory (Spare Parts generation,
development and requisitions) documentation compliance in order
to complete C&Q Validation activities
• Support the C&Q Teams in the resolution of discrepancies, and any
other situation that may disrupt the progress of the project to
continue as scheduled
• Equipment's Validated Wave Bioreactors, peristaltic pumps, tube
sealers, tube welders, shaker bases and scale
• As a facilitator, lead a team of SME to conduct varies types of
assessments, including risk assessments (CAPA, SARA, SICIA,
REM, and other risk tools)
Education
• Provide Project Management support in Design Review and University of Puerto Rico
Specification Compliance for Bidding Package preparation: Design BS Coastal Marine Biology
Humacao, Puerto Rico
Specifications, Facilities and Utilities Specifications, Piping
Requirements

Certifications
SPECTRAFORCE 03/2015 – 02/2016
Good Engineering Practices (GEP PALOOZA)
Instructor LED Training for Validation Good
Program Manager, Retail, Property, Management, Strategic & Engineering Practices for Design Deliverables
Administration (RPMSA) for the Hispanic Initiative Program Build Activities and Test Plan & Execution.
Development Genentech. 2009
Batch Record Review Right First Time
CVS Pharmacy, Corporate Office, RI
Metrics KAIZEN. GSK. 2007
Primary Responsibilities: Managed diversified working groups nationwide Primary Packaging Systems with Product
to maintain compliance in scope, budget and scheduling. Working in Contact (Bottles and Caps). TECH 070.0.
liaison with multiple Team Groups in the following: Glaxo Smith & Kline. 2006
Occupational Environmental, Security and
• Develop strategies to have working teams throughout the United
Health. 2006, 2010
Stated develop new initiatives such as the Hispanic Dominant
Advanced Professional Development Center.
Initiative, Over-The-Counter Health Solutions Initiatives, 2006
monitoring new store acquisitions in Florida, Hawaii and
Current Good Manufacturing Practices
California (cGMP's) for GSK
• Report financial development on new initiatives and their Advances Professional Development Center.
development in the current market 2006
• Prepare higher management presentations for the development of Certificate of Participation Continuing
new programs, updates on existing programs, presenting of Pharmaceutical Education
problem-solving solutions, alternatives and identified areas of Pharm-Tech Puerto Rico Conference; West
opportunities and development Rio Mar Beach Resort, Session SI- 410-000-
• Forecast financial conditions for future program development, 99-006-L04, Session S3-410-000-99-008-L04,
investments and resource acquisitions Session S7-410-000-99-012-L04, Session S13-
410-000-99-018-L04 and Session SC2-410-
Judge Group 10/2014 – 02/2015 000-99-002-L04. Total credits 1.7. 1999.

Sr. Technical Writer and Training Specialist
Genzyme-Sanofi, Framingham, MA
Primary Responsibilities: Support in the development and author of
various documents (PM, SOP) specific to equipment
operation/maintenance functions, for the Downstream Purification Project.
Also, worked in liaison between multiple Departments (Engineering,
Manufacturing, Quality Assurance & Control) and Subject Matter Experts
(SME) in the Facilities and Genzyme Capital Project Team departments in
the following capacity:
• Develop internal guidelines to facilitate the SME review of
documentation (via SharePoint)
• Collaborate with cross functional teams, to organize and prioritize
the Teams objectives in order to comply with HSE, QA and
Validation requirements on a timely manner
• Review, update and challenge SOP generated by the Engineering
team in order to ensure proper functionality use by the Facilities
Team operating under the respective SOPs.
• Train the Facilities Team in the approved operational and
maintenenance SOPs, and the use of the respective forms.
Independent Contractor 01/2013 – 10/2014

Business Analyst, Quality/Engineering/Compliance Consultant &
Professional Development
Worcester and Franklin, MA
Primary Responsibilities: Pursue further professional development
(presentation, seminars, Expos, Bio International Convention, BioNetwork
East, INTERPHEX, and ISPE 2013).
• Provide Consulting services to small to medium size businesses,
enabling personnel performance optimization, logistical
development, assessment (personnel, facility and
product/exposure) and proactive planning for future endeavors
• Support for future developing entrepreneurship businesses with
business plan development, for a competitive advantage (County
of Worcester, MA in collaboration with Entrepreneurship
Development, Government Funded)
• Consulting services for recurrent clients in the pharmaceutical
industries (Genentech, Amgen, Abbott, Merck): assessments
(facilities, production areas, validation plans) with short/long term
remediation plans, internal audit of controlled documentations
(review, approval routing process and formats), ensure
documentation compliance (SOPs in alignment with corporate
policies)

Hyde Engineering + Consulting 02/2009 – 12/2012

Sr. Consultant, Compliance and Technical Writer
Citra Labs, Braintree, MA 12/2009 – 12/2012
Primary Responsibilities: Generate Validation Documents
(IQ/OQ/PQ/PC/PV) and Engineering Test Plans, among others. These
documents are for equipment, process and utilities validation. Worked in
liaison with multiple Departments (Engineering, Manufacturing, Quality
Assurance & Control) in the following capacity:
• Execute and/or provide support during validation executions,
including trainings
• Create the baseline for a Validation Program
• Coordinate activities between Production resources and
Engineering
• Review, verify and reconcile executed data (Data Analysis, Root
Cause Analysis, CAPA, Risk Assessment, Quality Reports)
• Generate and develop all supporting documentation required for
the proper operability of equipment/systems/utilities
• Generation and/or review of SOPs, PMs, Control Procedures,
Studies, Annual Product Review, Validation Master Plan
• Ensure compliance within Manufacturing, Engineering, Quality
Assurance Departments with product requirements and
regulations
• Support the hiring process for department managers (ensure
technical qualifications required by the department are met)

Facility Reliability Assessment, Compliance Matter Expert
Merck, West Point Site, Lansdale, PA 10/2009 – 12/2009
Primary Responsibilities: Perform engineering assessment of the existing
facilities, processes, and procedures to assure long term reliable supply of
Merck's vaccine products. This facilities reliability assessment was
expected to generate a significant amount of data in the form of field
observations, document review and recommendations.
• Evaluate the present state of West Point infrastructure and
determine what obstacles exist within our facilities and systems
that are currently impacting supply or are likely to impact supply
in the near-term
• Identify potential sources of catastrophic risk (short term/long term
remediations)
• Ensure Compliance of current Gowning practices and consistency
in practices between the manufacturing plants
• Evaluate room classification (Grade A/B/C/D/Controlled
Unclassified)
• Evaluate Material/Equipment/Personnel Flows with current
standards and industry practices

Naderi Engineering 03/2009 – 10/2009

Commissioning and Qualification Documentation Internal Auditor
Genentech, HFF Plant, Hillsboro, OR
Primary Responsibilities: Ensure the compliance of the Commissioning and
Qualification activities (protocol generations, executions, test
documentation, summary report development and distribution of
controlled documentations), with the Quality Policy and Standards, SOPs,
cGMPs, GDP, GEP (Good Engineering Practices) and other requirements
(21 CFR Part 11, Parts 210 and 211, ISO 9000, ICH Q7A), in the following
capacity:
• Provide corrective and pro-active actions to upgrade and develop
better techniques for C&Q activities in accordance to Genentech
Policies, Procedures and Practices
• Revise Engineering and Quality Departmental procedures (SOP,
GMP, GDP and GEP) and training processes

INSCO 08/2007 – 03/2009

Project Manager
RUST Electrical Engineers, Thermo-electrical Power Plant, PR
Primary Responsibilities: Direct, enforce, optimize and develop
Instrumentation Termination personnel in the execution of Construction
Electrical work, performed for Puerto Rico's major power plant Palo Seco
Recovery Thermo-Electrical Plant, in the following capacity:
• Comply with administrative requirements within the company
(Staffing, De-Staffing, Training, Staff Development and
Coordination, Management Reports, Staff Development)
• Coordinate daily activities (workload, safety meetings, direct
report updates) in order to achieve maximum performance in areas
with limited access and personal space without affecting the
schedule and budget of the project
• Ensure the quality of work provided in a timely manner to meet the
client's requirements. Facilitate, at an engineering level, the
upgrade and highest efficiency of the work executed
• Ensure that all bill of materials and corresponding documentation
is on site and in place for use/references
• Coordinate, review, audit and generate the Turnover Packages
(Electrical Construction Documentation) of work completed, for
the Start-Up Team
• Consequently, assuring clients (PREPA) acceptance of work is
finalized (Complete Engineering Documentations in accordance
with Quality Specifications), Performance Walkthroughs and
Project CloseOut Walkdowns

VALCOA International 04/2006 – 08/2007

Business Developer
Pharmaceutical Clients, PR
Primary Responsibilities: Acquire new business contacts and contracts
within the Pharmaceutical Industry to enhance business development for
the company. Maintaining excellent relationships with current clients and
provide direct support when needed, in the following capacity:
• Develop and maintain new and current professional prospects
• Develop sales and communication skills within the company and
towards our clients
• Enforce personnel multitask development to optimize employee's
professional capacities within their field of expertise
• Generating project quotes to a competitive level within the
Pharmaceutical Market field (small consultant firm)
• Worked with Lilly Caribe, Wyeth Pharma, Ortho Pharmaceutical,
General Electric, IPR, Abraxis, Janseen, MYLAN,
VALEANT/Legacy, CORDIS, Baxter, Schering, McNeil (Johnson &
Johnson), BIOVAIL and Pfizer

Naderi Engineering 02/2002 – 04/2006

Batch Record Consultant for Third Party Auditors
Glaxo Smith & Kline, PR 03/2004 – 04/2006
Primary Responsibilities: Contractor for GSK, under Consent Decree, in the
Quality Assurance Department, reviewing the Batch Records for new
commercial product, in the following capacity:
• Assuring documentation compliance with Regulatory
requirements, SOPs, manufacturing and process specifications,
cGMPs and cGDPs, supporting documentation and other
commitments
• Relating auditing progress within the assigned group to maintain
outmost diligence and consistency in documentation and problem-
solving actions
• Update auditing techniques and developing outstanding
teamwork activities to maintain the revision and approval of the
lots documentation in constant progress to allow the
manufacturing departments planning on-going and the Batch
Documentation release certification by the Regulatory Agency
assigned by the FDA (in liaison with Quantic Regulatory Services)
• Monitor and develop a standardized Way-of-Working for both the
Manufacturing Batch Record Review group and the Quality
Assurance (Quality Operations) Batch Records Review group

Commissioning & Qualification (C&Q) Manager
Genentech, Porrino, Spain 02/2002 – 04/2004
Primary Responsibilities: Initially signed on as IQ Supervisor for the
Engineering Dept. During the progress of the project, promoted to
Commissioning Manager for the Avastin Clinical Trials Project, in the
following capacity:
• Coordination, development and monitoring of all Comm.
Activities in compliance with Engineering, Validation, Plant and
Quality requirements
• Ensure that all areas have progress metrics and that they are in
place
• Foster and ensure that all documents are delivered on a timely basis
for appropriate departmental tasks or operations
• Identify areas of concern and develop remediation strategies and
report overall and Departmental documentation progress
• Coordinate all Engineering Activities (SAT, C&Q, Engineering Test
Plans Activities)

INSCO 05/1999 – 01/2002

Project Manager
Multiple Pharmaceutical Companies, PR
Primary Responsibilities: Experience in generating job quotations for
subcontractor, planning, and construction, procurement and contract
administration, in the following capacity:
• Supported clients: Pharmacia, ABBOTT, Bristol Myer Squibb,
Amgen, Lilly, MSD, Wyeth.
• Ensuring prompt processing of documentation (including
pharmaceutical controlled documentation such as calibration
certificates, PMs, Spare Parts Lists, among others)
• Ensuring quality in materials, avoiding performance delays, and
claims delays to comply with an established termination date of a
project
• Complying with quality assurance and control programs (safety,
security, etc.)
• Manpower hiring, control and organization, generating efficient
project schedules, optimizing human/personnel resources
• Knowledge in cGMP, FDA, OSHA and other regulatory agency
requirements
• Subcontracting, expediting, inspections of materials, products
and/or resources
o Related to construction projects in (but not limited to)
chemical plants, consumer products facilities,
pharmaceuticals; at an instrumentation level
• Coordinate the installation of tubing, conduits, instrumentation
calibration and installation, junction boxes, control panels, loop
checks, performing testing on instruments and consequently the
system for validation purposes
• Ensure compliance with legal requirements, documentation and
regulatory affairs and providing quality deliverables in a timely
manner
• Respond efficiently to urgent and un-bided late requirements and
to the employees needs meeting our clients' demands

Alcon Pharmaceutical 03/1998 – 03/1999

Critical System Validation Supervisor
Humaco, PR
Primary Responsibilities: Coordinate Validation projects (Company
employees and sub-contracted companies) IQ/OQ/PQ/PV/RV and Media
Fills within the Ophthalmic for air systems, monitoring of nonviable
particles, utilities, microbiology of sterilization process (steam, dry heat,
Depyrogenation), sanitation process, validation of new formulas,
equipment, component preparation and packaging operations.

Amgen 02/1996 – 02/1998

Quality Assurance Lead
Juncos, PR
Primary Responsibilities: Maintain and improve the Quality Events Data
Base (Quality Deviations Information System and Registration), in the
following capacity:
• Generate, develop and execute a training program for the Quality
Events Data Base
• Assure that all controlled documents are properly processed,
approved, translated and archived in a timely manner
• Coordinate and execute internal audits
• Assure the implementation of the Corporate Quality Policies in the
local SOP among other documents
MOVA 03/1994 – 01/1996

Validation Specialist/Aseptical Manufacturing Group Leader
Caguas, PR
Primary Responsibilities: Collaborating in the process of generating,
developing, translating and activating SOPs, as well as providing technical
support to areas, in the following capacity:
• Aseptical MFG Group Leader- Active participation in the
coordination of the manufacturing processes (equipment
preparation, formulation, filling and packaging of parenteral
products), inspection of raw material and final labeled vial product
• Validation Specialist- Assure the integrity of aseptic
pharmaceutical processes, which include the validation of cleaning
equipment (stopper washer machine, depyrogenation ovens,
autoclaves, vial washers, among others) and packaging processes,
utilities (steam systems, vacuum systems and water systems),
sterilization processes and sanitization processes.

McNeil Pharmaceuticals 10/1992 – 03/1994

Manufacturing Group Leader
Juncos, PR
Primary Responsibilities: In the granulation and compression area of solids,
responsible for coordinating production personnel activities ensuring
materials for production, documentation and personnel properly
organized for a successful production shift, in the following capacity:
• Coordinating and providing required trainings for personnel
• Maintain a highly motivated work environment
• Provide safety conferences related to the immediate working area
daily
• Assure proper documentation practices on all control documents
(manufacturing logbooks, batch records, training forms,
cleaning/process and production forms, etc.)
• Audit and ensure compliancy to cGMP and GDP are met

  • Updated 3 years ago

To contact this candidate email rodriguez_camelia@hotmail.com

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