Job Description Business: Critical Care Department: Quality Assurance Location: Bethlehem Job Overview Overall responsibility for Operations QA GMP functions including batch record reviews/dispositions, deviations and CAPA, OOS resolutions, QC data reviews, and management of drug product complaints. Key Stakeholders: Internal Manufacturing, Packaging, Engineering, QC, RA, Supply Chain, Project Management, Sales Key Stakeholders: External Other Piramal groups, vendors, distributors, and clients Reporting Structure Reports to Associate Director of Quality Assurance Essential Duties and Responsibilities
- Overall responsibility for coordinating the disposition of API and drug product
- Coordinates batch documentation review with Operations groups to ensure GMP compliance and timely delivery of products to customers
- Ensures all documentation and API/drug product batches produced meet the requirements of GMPs and other regulatory health authority requirements
- 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 in EU/UK QA to ensure batches are dispositioned 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
- Prepares metrics for weekly, monthly and quarterly Management meetings
Key Competencies (knowledge, skills, and abilities every person must possess to be successful), i.e.
- 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
- Demonstrated ability to evaluate quality matters by leveraging GMP experience, analyzing data, while using FDA Risk Based type approaches
- 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
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.