U.S. Cit / Northern NJ / no relocation / commute to South / Central NJ, Rockland and Westchester Counties
MS Management, BS Chemistry
Available for contract or full-time employment
Medical Devices, consumer products and pharmaceuticals
QA Compliance, Submission Ready Components, product complaint investigation including understanding of CFR, ICH and ISO within the medical device, pharmaceutical and Biopharmaceutical global operations. Skilled at working independently with little or no supervision, or as a part of a team. Adapt at dealing with people of diverse personalities and maintaining a calm demeanor in difficult situations.
MS in Management,
Stevens Institute of Technology, Hoboken NJ
BS in Chemistry (Minor-Microbiology),
Mumbai University, India
Validation and Regulatory Certification course,
Stevens Institute of Technology, Hoboken NJ
Microsoft Office Certification Program for Client Service Administration and Developer, Synergistic Computer Learning Center, Elmwood Park, NJ
Enterprise Systems Implementation
Document change Control
Pharmaceutical Manufacturing Processes
Implementation of Quality System manuals
Siemens ERC, PQC, CAPA, Audit process
TECHNICAL PROFICIENCIES & TRAINING:
Quality Auditing and Records Management, Comprehensive Office Ergonomics, OSHA Certification, Submission ready Components (SRC), Lean Six Sigma (Red Belt), Project Management, Complaints management (GSMS system), SAP ECC 6.0
March 2015 to Present: Quality Engineer (Position through Randstad)
Responsibilities incudes but not limited to process safety complaints and confirmed product complaints, prepare and submit initial and supplemental medical device reports, ensure the integrity of complaint files and the complaint handling process, contribute to the improvements in complaint handling, product quality, and customer experience. Work closely with a cross-functional team, including Headquarter Support, Manufacturing, Commercial Product Quality and R&D.
Perform prompt escalation and complete the documentation of product safety complaints from start to finish including submission of initial and supplemental Medical Device Report (MDR)s using eSubmitter, within specific due dates and in accordance with the FDA regulations.
Contribute to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions).
Ensure complaint documentation and records are complete and in compliance with regulatory requirements.
Participate and support internal, external audits /inspections.
Familiar with Siemens ERC, PQC and CAPA handling systems and workflow.
Provide support in all areas associated with MDR/MDVR/MDPR reporting and trending.
Exercise strong critical thinking to bring successful resolutions to high-impact, complex problems.
January 2014 to January 2015: R & D SAP/PLM Specialist (Position through Mindlance Inc.)
Supported the BD-Medical Surgical Systems R & D as a Senior PLM specialist in coordinating inputs and Management of data within SAP ECC 6.0 that directly impacts time to market for high volume disposable medical devices.
Define, identify and execute project activities focused on the SAP Material Master Data and Document Management System
Provide support for the product development life cycle within SAP and work cross-functionally and effectively with multiple remote sites
Collaborated with QA and Master Data Management team to create required master Data for R & D Projects
Gathered and documented business and functional requirements. Solved problems through issue based problem solving principles.
Design History Files (DHF) Project – Find and collate the DHF files, review for completeness and manage the information using MS Excel database.
Unique Device Identification (UDI) project- Identify and review medical device labels for UDI implementation project. Manage documents through SharePoint Site.
March to December 1998* and July 1999-October 2012: Document Control / QA Specialist, (QA Records Management and Compliance Audits)
Interacted with all levels of the organization to review and complete the Site procedures, assessments, remediation plan for audit verification, and project implementation of assigned Quality Standard Manuals
(QSM) / Company Quality Standards (PQS). Generated reports using database queries, worked closely with Quantic consultants for cGMP assessments, remediation and training. Interviewed laboratory personnel to obtain information for laboratory equipment, notebooks, validation documents, etc. Compiled and managed the information in MS Access/Excel databases. Extensively used SharePoint sites for collaborating with various Pfizer sites. Authored and implemented electronic site procedures including the Protocol to implement PQS at Pearl River Site and trained SMEs for the same. Implemented and managed document change control procedures as per 21 CFR part 11
GM/GXPharma Business Administrator: Reviewed, approved, issued and made effective over 1000 regulated documents (SOPs, Forms, VAL docs. Etc.). Troubleshoot GXPharma system problems.
Collaborated SMEs to complete Compliance Analysis Summaries (CAS) for over 120 Pfizer QMS/PQS
Created and implemented comprehensive needs assessment mechanism to help evaluate and implement these documents at site level.
Provided continuous support to strategize, prioritize and close investigations, including product complaints and CAPA.
Successfully executed PQ for the Batch Print Server as a member of validation team and managed migration of 1200 plus regulated documents in GM/GXPharma. Worked diligently with other IT groups to plan and support GM/GXPharma systems.
Qualified calculators and implemented programs to qualify laboratory calculators, MS Excel Spreadsheets.
Managed Document Control Room along with site admin for successful Regulatory, Corporate and other internal/external Audit/Inspections. Managed SharePoint site for PQS implementation and Safety Committee.
Collaborated with audit group for internal / external Audit and Inspection readiness such as GCA, FDA and PAI, etc. Initiated 200 plus Commitment/Notifications in Trackwise/SAP CAPA for audit commitment. Assisted QA Audits group during the Corporate and FDA third party [Lachman] audits related to cGMP compliance which resulted in successful Consent Decree verification.
Trained internal/external customers for Migration and Document Life Cycle Management procedures.
Actively participated in OSHA VPP certification Program for Pearl River Site. Conducted pre-inspection safety audits for offices and production floor.
Performed monthly housekeeping audits as a Compliance & Safety Evaluation Program Chairperson. Lead Pearl River EHS Office Safety and Site Office Ergonomics Evaluations committees.
Received Star awards under the Above and Beyond program Received certificates for Safety Awareness.
October 1989- March 1997: Medical Technologist
Administration: Maintained computerized records/statistics to comply with FDA and OSHA regulations.
Technical: Inoculated, isolated and identified organisms and viruses like C. Difficile, HSV, VZV, CMV, RSV
Influenza Viruses, etc., using standard tissue cultures, shell vials, assays, ELISA Assays, Haemadsorption,
Haemagglutination and other techniques. Carried-out robotic laboratory analysis for detection of Chlamydia. Also performed direct immunofloresence staining with fluorescent labeled monoclonal antibodies Performed Recognition: Received “Great Idea Award” for providing cost saving idea in the Virology lab.A109
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