Quality Systems Engineer - CAPA (Contract)

Plymouth, MN

3458 Pilgrim Lane N (917) 929-3591 Plymouth, MN 55441 jatinjansari711@gmail.com

Acquired knowledge and have excellent abilities assisting in regulatory submissions for a Novel Drug/Medical Device pertaining to FDA, EMA, TPD and TGA, in maintaining Compliance with cGMP (21 CFR 211) and QSR (21 CFR 820), Six-Sigma-Lean and in in-process and finished product analysis, test method validation for quality control and internal and external agency audits (TUV)
Special competencies in GxPs, Investigational New Drug Application, Investigational Device Exemption (21 CFR 812), Quality System Regulation (21 CFR 820), Combination products regulations (21 CFR 4), Medical Device Reporting (21 CFR 803) for US and European markets, Medical Device Directives 93/42/EEC, 90/385/EEC and 98/79/EC, MEDDEV documents, ISO 14971, ISO 13485, ISO 9001, ISO 10993, and in Advanced Analytical techniques like HPLC, UV-Spectrophotometry for sample analysis, Process Validation (IQ/OQ/PQ), TrackWise, Minitab ANOVA, Enovia, Agile, Packaging Inspection, DOE (Design of Experiments), DMAIC approach, pFMEA, dFMEA, uFMEA, Process Mapping, Internal Audit, External Audit, TUV, CAPA, Test Method Validation, Visual Inspection, Gauge R&R, Coating process

Master of Science, Regulatory Affairs for Drugs, Biologics and Medical Devices (GPA: 3.31) June 2013
Introduction to Drug and Medical Device Regulations, Human Experimentation: Methodological Issues fundamental to clinical trials, Advanced Writing on International Biomedical Topics, A QA/Regulatory overview of New Drug, Biologics and Medical Device Development, European Union Compliance Process and Regulatory Affairs, FDA Law, European Medical Device Regulation, Strategic Planning and Project Management for Regulatory Affairs
Bachelor of Pharmacy June 2011
Pharmaceutical Sciences, Pharmacology, Industrial and Clinical Pharmacy, Medicinal Chemistry, Analytical Chemistry

Medtronic – Quality Systems – Coronary and Structural Heart (www.medtronic.com) Brooklyn Park, MN
Quality Systems Engineer – CAPA (Contract) November 2015 – Present
– Identified all Site documents and currently working on a Reconciliation Plan with the Site QA Leaders/Document Owners to analyze their site QMS documents to define opportunities for clean-up post Phase I Harmonization efforts with the help of Decision Tree
– Facilitated the development, implementation, maintenance, training and continuous improvement of the Quality System
– Assisted in preparation for and support external regulatory and notified body, TuV audits
– Assessed compliance and effectiveness of the Quality System with respect to relevant regulations, Corporate Policies, employee training records

Terumo Cardiovascular Systems – FDA Consent Decree Remediation (www.terumo-cvs.com) Ann Arbor, MI
Validation Consultant, Engineer II (Resigned the contract) April 2015 – October 2015
– Assisted with cause-identification and problem-resolution for various types of production or service-related issues
– Authored Engineering Analysis study protocol/reports for the process improvement projects by working cross-functionally with SMEs from Quality Assurance, Operations Engineering, Design Assurance and Statistics
– Authored Test Method Validation protocols/reports for validating the existing tests within the process, leading to development of Installation, Operational and Performance Qualification (IQ/OQ/PQ) protocol/reports for the manufacturing machine/equipment
– Conducted Technical Reviews for the updates on Manufacturing Work Instructions and relevant pFMEA documents
– Worked closely in coordination with the Manufacturing Chemists to validate the process by running Design of Experiments (DOE) and analyzed the results for process optimization
– Provided engineering input in the design, fabrication, development, installation, validation, and qualification of equipment / processes which may include feasibility studies and/or proper documentation for justification of project and training to ensure proper operation of the equipment
– Provided assistance for planning and implementation of projects to develop, install, and qualify new processes for manufacturing new products or improving existing processes
– Gathered, tracked, and analyzed production data for meetings, business plan, etc. (yields/output/efficiencies)
– Demonstrated a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures

Zimmer – CAPA Remediation & Acceleration (www.zimmer.com) Warsaw, IN
CAPA Engineer (Contract terminated) November 2014 – January 2015
– Provided leadership for CAPA projects from Issue Identification through Investigation, Implementation & VoE – including design, implementation, testing, documentation, support, and maintenance and created CAPA – Lessons Learned documents for possible CAPA trends.
– Responsible for gathering relevant, factual information and data in order to solve quality related issues
– Facilitated team efforts on quality engineering projects, created training memos and CAPA Investigation Summaries for closure of CAPAs

AbbVie – Quality & Compliance (www.abbvie.com) Waukegan, IL
Regulatory/Quality Intelligence Associate (Contract ended) February 2014 – October 2014
– Searched, compiled, organized and analyzed internal and external regulatory intelligence (FDA warning letters, Inspection Form 483s, Eudra-Non-Compliance reports, Recalls etc.) related to biopharmaceutical and medical devices for scheduled reporting.
– Developed, established and maintained databases, spreadsheets and SharePoint sites and acted as a dedicated support for technology platforms
– Supported the trending and tracking of key metrics for the Site Compliance Knowledge Management program and disseminated regulatory, quality and compliance intelligence in a bi-monthly meeting for the AbbVie Global Organization to effectively achieve the company’s regulatory compliance goals and objectives
– Researched and summarized new and revised regulations, rulings, directives, guidance documents, standards and regulatory activities to main regulatory bodies that may impact AbbVie quality systems and subsystems
– Performed maintenance of regulatory intelligence data and distribution lists in a central repository, triaged data by product type, and by relevant quality system
– Updated Audit database by creating auditee, audit, observation and CAPA records in to TrackWise system in accordance with AbbVie’s Quality System Document and generated audit tracking reports by exporting
– Performed tracking of audit observation CAPA Plans from the assigned SMEs and maintained and submitted tracking spreadsheets to keep up with the planned delivery deadlines for AMRs/QMRs
– Executed technical tasks in support for investigation, implementation and verification of effectiveness for CAPAs which included updating procedures, work instructions, forms, training requirements, test methods
– Created a whole new Access Database by working cross-functionally with Business Excellence and IT by using Six-Sigma-Lean tools like Process Mapping and Just-In-Time approach to make the intelligence process streamline

InvaGen Pharmaceuticals Inc. – Quality Control – Finished Products (www.invagen.com) Hauppauge, NY
Quality Control Analyst (Full-time role) September 2013 – February 2014
– Developed, validated and facilitated inter-laboratory transfer of analytical methods for active pharmaceutical ingredients and dosage forms
– Received and authorized the receipt for Analysis Request and loaded the In-Process and Finished Product samples from different batches for various types of analysis (Blend Uniformity, Composite Assay, Content Uniformity, etc.) electronically in to the InvaGen’s SampleLogin Database on a day-to-day bases
– Reviewed and applied laboratory Standard Operating Procedures (SOPs) and supported the execution of approved protocols for the validation of analytical instruments and test methods
– Tested drug substances, intermediates and raw materials while conducting impurity profiles for dug substances and intermediates
– Documented laboratory investigation, deviations and incidents and prepared Product Specification and Release Reports and In-Process Specification and Release Reports
– Coordinated and assisted in documentation of CAPAs and change controls
– Worked with advanced analytical equipments like HPLC, UV, etc while applying knowledge of broad variety of analytical techniques and performed monthly calibrations of advanced analytical equipments
– Analyzed the drug samples for the content uniformity through High Performance Liquid Chromatography (HPLC) with the help of the TotalChrom™ Chromatography Data System (CDS) and TC Publisher™ Chromatography Reporting System (complied with 21 CFR 11)

Planet Health, GPSAR Healthcare Ltd. – Retail Pharmacy (www.planethealth.in) Ahmedabad, INDIA
Pharmacist (Full-time role) May – October 2011
– Advised patients on proper dosage in order to maintain customer satisfaction levels and patient compliance and performed patient-counseling, examined medical prescriptions and dispensed the medicines confidentially and in obligatory manner
– Investigated and reported customer complaints concerning the use of the medical devices (like Blood Pressure Monitors, electronic thermometers, etc.) and restored the devices with satisfactory customer levels
– Conferred with physicians on special occasions to resolve various prescription discrepancies that could concern acute, chronic, genetic, delayed adverse events and drug-to-drug interactions for the ease and aid of patients
– Evaluated patients’ safety data and identified, where possible, ways to avoid adverse reactions (dosing, monitoring) and ways to manage them when they occur
– Worked on post-market surveillance activities for the medicinal and medical device products being sold
– Collected and documented SAEs (serious adverse events) within a determined time-frame pertaining to patients’ medications and reported it to the corporation for an immediate follow-up action with relevant pharmaceutical firms
– Keyed in the medicinal products’ information accordingly in to the pharmacy’s computer database system for the received goods and authorized the indent
– Maintained and documented patients’ sickness and medication data reviewed and updated it on regular intervals for the changes in the medication and/or dosage and patient conditions.

West-Coast Pharmaceutical Works Ltd. (www.westcoastin.com) Ahmedabad, INDIA
Quality Assurance Coordinator (Internship to Full-time hire) July 2010 – April 2011
– Reviewed documents and created Quality Operating Procedures, Risk Analysis Reports, Inspection Records and associated records
– Inspected and reviewed documentations for labeling of the finished products and released them in accordance with the specific written procedures
– Assisted the manager to accomplish the internal quality audit and developed the audit reports and Corrective Actions Preventive Action reports
– Surveilled site of production on regular bases and reported contamination and packaging deficiencies to ensure persistent product quality
– Corresponded the manufacturing manager on regular intervals for batch variations and issues resulting from recorded reviews, internal audits of facility and deviation issues and resolve any quality concerns of the final product

– Wrote a review article on “Application of Biopharmaceutics Classification System in Formulation Development” which was published in Pharm Tech Medica, an official international journal (www.pharmtechmedica.com)
– Northeastern University:
• New Drug Application submission: Corresponded as a company statistician and exhibited solid statistical data for our product in a group presentation exercise for NDA submission as per 21 CFR 314
• Comprehended the modules of Common Technical Document (CTD) for an NDA submission and followed the steps for a sample eCTD submission with the help of guidance documents
• Pre – IND meeting: Part of the pre-Investigational new drug meeting executed as a class exercise as per 21 CFR 312.82(a) and represented as a of lead of the quality-assurance department for the FDA submission in group exercise and worked collaboratively with other teammates to pose strong grounds for approval of IND submission
• SOP: Prepared scrutinized Standard Operating Procedures under the Good Laboratory Practice part of 21 CFR 58.81
• 510(k) submission and EU submission: part of the class practice for the traditional, special and abbreviated 510(k) submission and fictitious class IIb medical device regulatory strategy development process for US and EU resp.
• Created a product specification sheet and made a risk analysis plan for a fictional AFib Ablation Catheter device in accordance with ISO 14971 and created a test plan for Validation and Verification (V&V)
• Prepared a Global Regulatory Strategy for US, EU, Canada and Japan after freezing a product design and created Pre – IDE meeting submission with objectives, product specifications, proposed V&V testing plans and clinical protocols with draft meeting minutes
• Guided clinical team while developing clinical protocol for feasibility study based on reviewing FDA guidance for an AFib indication
• Reviewed and approved V&V bench test protocols, V&V bench test reports, Accelerated aging protocols & reports and Real time aging protocols for the catheter device as follows: Electrical Testing and Mechanical Testing such as bond strength as per ISO 10555-1
• Reviewed ISO 10993-1 guidance document, categorized catheter device and decided the required biocompatibility testing
• Provided guidance to teams for developing labels and Instruction for Use (IFU) (21 CFR 801)
• European Medical Device Submission: reviewed Directive 90/385/EEC, 93/42/EEC and 98/79/EC for the conformity assessment and marketing strategy project for a fictitious cochlear implant(active implantable), a fictitious contact lenses (class IIb) & a fictitious jet injector (class IIa) and an in-vitro diagnostic device respectively with the help of MEDDEV guidance documents

  • Updated 7 years ago

To contact this candidate email jatinjansari711@gmail.com

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