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Job Details

Sr Quality Assurance Manager - Pharma

Company: Barrington James Clinical
Location:
Reference: CRBG - SRQAMAN
Closing Date: 03 Feb 19
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

The Sr. Manager QA will support the QA Director on the assessment of cGMP compliance of pharmaceutical production of API, Bulk Drug Product and Finished Product at the external outsourced manufacturing facilities; technology transfer and validation documentation; cGDP compliance of pharmaceutical product distribution; and the maintenance of a functional and inspection ready internal Quality System.

Requirements:

Main Responsibilities:

  • Work across all functions to ensure that Quality standards are maintained within the Company
  • Provide quality guidance to product development / tech transfer projects
  • Maintain the documentation system by co-writing and updating quality assurance policies and procedures
  • Propose Risk Evaluation tools and Mitigation Strategies
  • Write/review/approve analytical methods (transfer and validation) protocols and reports
  • Write/review/approve process validation protocols and reports
  • Approve supplier’s CAPAs and deviation reports, change controls, complaints
  • Review and approve batch documentation, and transportation records according to GMP/GDP
  • Support GMP/GDP vendor auditing program

Required Background and Skills:

  • A minimum Master Degree in a scientific field (Pharmacy, Chemistry, Biology)
  • A minimum of 10 years’ experience in pharma/biotech industry (manufacturing, QA/QC) of which a minimum of 5 years in QA
  • Previous operations experience in a manufacturing facility of solid dosage forms and/or injectable is considered a strong plus
  • Previous experience in of Technology Transfer Projects as part of Manufacturing and/or QA Team
  • Team player and excellent communication skills
  • Excellent organizational skills and great attention to details
  • English is the company language

Apply for this job: Sr Quality Assurance Manager - Pharma

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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