A cutting edge pharma organization is looking to make a new hire of a Manager of Quality Engineering: Commissioning & Qualification. With a drive to develop and deliver a large variety of lifesaving therapeutics to treat disorders, this global biotechnology leader is looking to expand its team.
- Support QA oversight of quality standards and systems aligned with the Engineering function in the above areas.
- Oversee all transfers to commercial, internal & external: Commissioning & Qualification, , Commissioning, Qualification, System Verification/commissioning, URS, Risk analysis, IQ/OQ/PQ, Requalification , SOPs review & approval, Deviation (oversight), Changes, Inspections
- Conduct Quality Assurance Oversight activities including risk management
- Collaborate with internal partners for the execution of all capital projects
- 5+ years' GMP experience in pharmaceutical/biotech/or other regulated industry
- Knowledge of current Good Manufacturing Practices (cGMP) principles
- Knowledge of appropriate regulatory requirements