Ensure GMP compliance and timely delivery of products to customers by overseeing documentation review, batch production, and quality control data.
Requirements
- 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.
- Demonstrated ability to evaluate quality matters by leveraging GMP experience, analyzing data, while using FDA Risk Based type approaches
Responsibilities
- Ensures all documentation and API/drug product batches produced meet the requirements of GMPs and other regulatory health authority requirements
- Ensures 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 OOS results 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 in EU/UK QA to ensure batches are released and records provided in a timely manner
- 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
Other
- Coordinates batch documentation review with operations groups to ensure GMP compliance and timely delivery of products to customers
- Supervises day-to-day functions of the QA Operations team
- Mentors/coaches and provides succession planning for direct reports
- Prepare metrics for weekly, monthly and quarterly Management meetings
- Critical Thinking skills using “Risk Based” logic and reasoning to identify the strengths and weaknesses in QMS, recommend and institute solutions, conclusions, and approaches to problems
- Attention to detail/ sense of urgency- ability to act quickly and escalate issues
- Excellent customer service skills and professional demeanor always to interface effectively with all internal and external customers
- Excellent verbal and written communication skills
- Energetic, enthusiastic, and motivational disposition
- 10+ years’ experience in Pharmaceutical/Biotech industry
- BS preferred or combination of education and relevant experience
