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Quality Assurance Operations Supervisor bei PPL Corporate-Human Resources

PPL Corporate-Human Resources · Bethlehem, Vereinigte Staaten Von Amerika · Onsite

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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.

  • 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 

  • BS preferred or combination of education and relevant experience
  • 10+ 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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