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GMP Quality Assurance Manager Contractor for TOP PHARMA COMPANY

  • Job type: Contract
  • Location: Philadelphia
  • Salary: Competitive
  • Job reference: AC/NJ/QA
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 30/01/2018
Associate GMP Quality Assurance Manager

The Manager of Quality Assurance will report to the Associate Director or Director of Quality Assurance. This position will ensure that procedures are implemented to maintain compliance to the quality systems requirements as defined by the quality system manual. Responsible for implementing and maintaining the effectiveness of the quality system.

This opportunity is with a rapidly grown pharmaceutical company that is known as the world’s leading manufacturer and marketer of generic drugs.

  • Plans and develop audit calendar/program, leads external and internal audits
  • Develops with the CMC team and CMOs: DS, DP, Key Raw Material & Intermediates specifications and stability requirements; Master Batch Records; validated manufacturing processes and analytical methods; CTM and commercial packaging and labeling
  • Reviews and monitors release and stability data
  • Monitor and provide corrective action recommendations to compliance issues and/or observations as they arise.
  • Review and approval of (but not limited to) batch records, change controls, deviations, CAPAs and effectiveness checks, laboratory investigation reports, SOPs, forms, work instructions, CoTs, CoAs, release of raw materials, and product disposition.
  • Training of personnel and provide GXP training as required
  • Represent the quality assurance department on cross-functional project teams. 
  • BA or BS degree in a scientific discipline preferred, or comparable experience. 
  • Auditing experience in a GMP and GCP environment
  • Knowledge of US & EMA & ICH regulations/guidance for CMC and GMP/GCP
  • 2+ years in pharmaceutical Quality Assurance
  • Proficient in Microsoft Office 

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