Quality Assurance Operations Supervisor

Be the First to Apply

Job Description

Essential Duties and Responsibilities

• 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 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
• Prepare metrics for weekly, monthly and quarterly Management meetings
• Any other duties as assigned

Qualifications

Key Competencies (knowledge, skills, and abilities every person must possess to be successful), i.e.

Education / Experience

Job Info

Show more

Show less

Skills Required

Lms, trackwise , Edms