Job Description

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

• Bachelors 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.

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