- 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
- 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 (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
- BeOne Medicines (San Carlos, CA)
- BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Senior Manager , Systems Validation in San Carlos, CA: **Job Duties:** Manage the entire GxP change control process ... and revise accordingly based on guidance and feedback from Quality team. Manage validation activities of cross...21 CFR Part 11, 210 & 211, GLP, GCP, cGMP (current Good Manufacturing Practice) regulations. Any suitable combination… more
- Curia (Rensselaer, NY)
- …in a cGMP regulated industry specific to computer systems validation + Validation experience in a cGMP quality control laboratory or sterile fill ... Quality team. This role is responsible for supporting Quality Management Systems and Computer System Validation ...date trainings + Other duties as assigned by QA manager and/or QA director Education and Experience: + Bachelor's… more
- PCI Pharma Services (Philadelphia, PA)
- …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
- 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)
- …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
- Pfizer (Andover, MA)
- …within a cGMP biopharmaceutical manufacturing facility. + The Principal Cleaning Validation Engineer is a member of the Andover STS Technical Programs team ... the world. **What You Will Achieve** The Principal Cleaning Validation Engineer is a team leader role responsible for...and reports to the Site Technical Services Technical Programs manager . This role provides leadership and technical support and… 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