What are the responsibilities and job description for the Quality Assurance Supervisor position at Germer International - Pharmaceutical Recruiting?
Our client is seeking a Quality Assurance Supervisor to oversee batch documentation review and serve as a key liaison with Operations and ensuring that all documentation aligns with GMP standards.
Responsibilites
- Supervises day-to-day functions of the QA Operations team
- Mentors/coaches and provides succession planning for direct reports
- Ensures batches meet GMP requirements and all production and QC documentation has been reviewed prior to disposition
- If any errors or data integrity issues occur during the manufacturing, packaging, labelling, and testing of API/drug product, that they have been investigated according to internal procedures.
- Ensures QC data meets specifications and any OOSs are investigated per internal procedures
- Provides QA presence on API/drug product filling/packaging line through documented walkthroughs to ensure GMP compliance
- Works with global partners
- Manages drug product complaint program ensuring samples are received in a timely fashion and investigations meet established internal procedural requirements and reports back to customer service team through approved software programs
- Prepares metrics for weekly, monthly and quarterly Management meetings
Education/Experience
- Bachelor’s degree required with Bachelor of Science preferred
- 5 years’ experience in Pharmaceutical/Biotech industry
- Experience in TrackWise, EDMS, LMS or other such software tools for managing the QMS
- Working knowledge of 21 CFR part 210/211, and part 11, FDA guidance. Knowledge of 21 CFR part 820 Medical Device Regulations preferred.
Salary : $90,000 - $120,000
