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North Brunswick, NJ, 08902
... Experienced in Corrective and Preventative Action (CAPA) in analytical roles. Knowledge of 21 Code of Federal Regulation parts 11, 50, 54, 56, 312, 314 Capable of Serious Adverse Event (SAE) reporting and Individual Case Safety Reporting (ICSR). ...
- 2023 Dec 22
New York, NY
... April 2016 Speaker for CAPA Conference, “What Do You Need To Prepare to Tour Internationally?”; Liuzhou, China; April 2016 Panelist on International Arts Market & Touring Sustainability for Artists from ASEAN Countries for Tini Tinou International ...
- 2023 Dec 22
Edison, NJ
... • Highly experienced in CMMS maintenance systems (Infor and Blue Mountain) and Trackwise quality systems for change control, CAPA’s and deviation investigations. • Install, troubleshoot, and maintain GMP validated equipment for production lines and ...
- 2023 Dec 20
Jersey City, NJ
... Professional Experience: LUPIN Limited, India (USFDA, MHRA, TGA, ISRS WHO GMP certified) Feb 2021 – Aug 2022 Quality Assurances Officer (QC Documentation & QMS Section) ·Responsible for QC change controls, CAPA, effectiveness check actions & QRM ...
- 2023 Dec 05
Parsippany, NJ
... Key Strengths Strategic Operations Leader Manpower, Manufacturing & Production Planning Quality Assurance, RGA & Scrap Reduction, Capa’s Product Coordination and Development Customer Service Inventory Management Work History Euroimmun – Lead ...
- 2023 Nov 17
Somerset, NJ
... Highly effective at contributing to drug development and technology transfer, facilitating GMP audits, CAPA, and root cause analysis, and clearly and concisely liaising with agencies and clients. Encouraging mentor, excellent team leader and ...
- 2023 Nov 16
New York, NY
... • Played a central role in ensuring hospital-wide QA and compliance with 120 accreditation parameters, and contributed in auditing, 5 gap analyses, and generating CAPA reports. Operations & Compliance Trainee Nov. 2017 – Mar. 2020 DY Patil ...
- 2023 Nov 08
Paterson, NJ
... ●Experience in reviewing and approving requirements, test scripts (pre and post) and defects in ALM (Vera Template) ●Experience in performing Gap Analysis, Root Cause Analysis, Corrective and Preventive Actions (CAPA) Reporting. ●Excellent knowledge ...
- 2023 Nov 02
New Brunswick, NJ, 08989
... (i.e Deviation, CAPA, Protocol, Report, PMR, SOPs etc.) Coordinate with QA and warehouse personnel to ensure availability of required materials. Motivate a diverse workforce of all employees to exceed department goals, which includes safety, quality ...
- 2023 Oct 30
Piscataway, NJ, 08854
... and issue material status notifications Facilitated and participated in deviations, corrective action and preventive action (CAPA) activities, and complaints for assigned projects Served as QA lead on project teams, in complex quality investigations ...
- 2023 Oct 25