- Honeywell (Baton Rouge, LA)
- The Quality Assurance (QA) Manager oversees, implements, and maintains cGMP compliant systems and activities. Incumbent is also responsible for evaluating ... internal controls and maintenance of cGMP documentation for compliance with quality and regulatory standards. The GMP QA Manager also monitors Contract… more
- Houston Methodist (Houston, TX)
- …and prioritize daily tasks **GROWTH/INNOVATION ESSENTIAL FUNCTIONS** + Participates with the Quality Assurance Manager and/or cGMP Core Director in ... defining quality policies. + Assists Quality Assurance Manager , cGMP Core...of biotechnology or pharmaceutical industry experience with exposure to cGMP manufacturing operations + Experience performing equipment validation… more
- WuXi AppTec (Middletown, DE)
- …seeking a highly experienced and detail-oriented **CQV (Commissioning, Qualification, and Validation ) Manager ** to lead the execution of commissioning ... alignment on validation strategies includes CSV strategy. + Coordinate with quality and manage the deviation and change control procedure during CQV phase. +… more
- Bristol Myers Squibb (Summit, NJ)
- …Minimum 5 years of experience or more in pharma/biotech, with focus on IT - Validation and Quality Assurance & Compliance + Experience with MES platforms (Syncade ... . **About the Role** This position will drive computer system validation activities for the Summit site Manufacturing Execution Systems (MES) supporting… more
- Bristol Myers Squibb (Indianapolis, IN)
- …entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT Process Lead is ... address process deficiencies. Work collaboratively with peers within various departments and Quality groups. + Provides validation subject matter expertise (SME)… more
- Pfizer (Sanford, NC)
- …and SMEs to support cGMP and site training initiatives, reporting to the Validation Section Manager and summarizing data into concise reports for review and ... this role, you will: + Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with...standards. + Work effectively as a member of the Quality Operations (QO) cGMP training team, collaborating… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …formulation. The **Senior Validation Specialist** with guidance from the Validation Manager , defines and implements procedures and processes to assure ... that pertain to Installation, Operational, and Performance Qualification. + Assuring cGMP compliance related to Qualification and Validation of… more
- PCI Pharma Services (Rockford, IL)
- …of corrective action to complete the project. 7. Primary contact for quality validation activities and managing expectations. 8. Reviews and interprets ... meetings. Effectively communicates project goals and progress to the Validation Supervisor / Manager . 6. Investigates ...protocols. 9. Knowledge of and adherence to all PCI, cGMP , GCP, GAMP, 21CFR, 21CFR Part 11, and Annex… more
- PCI Pharma Services (Rockford, IL)
- …resolution of corrective action to complete the project. Primary contact for quality validation activities and managing expectations. Reviews and interprets ... meetings. Effectively communicates project goals and progress to the Validation Supervisor / Manager . Investigate validation... protocols. Knowledge of and adherence to all PCI, cGMP , GCP, GAMP, 21CFR, 21CFR Part 11, and Annex… more
- AbbVie (North Chicago, IL)
- …Validation Section Manager , will participate in the implementation of the Validation quality program, but s/he will be expected to independently manage 5+ ... Validation Specialists + This role serves to provide Quality Assurance oversight of site validation documents/...to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation + May supervise… more