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Senior Quality Assurance Specialist

1 month ago

Birmingham, Birmingham, United Kingdom Nicholas Associates Group Limited Full time

**Job Title:** Senior Quality Assurance Specialist

**Job Summary:** We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Nicholas Associates Group Limited. The successful candidate will be responsible for ensuring the quality of our pharmaceutical products and services.

**Key Responsibilities:**

  • Support the team's efforts to maintain GMP and GACP compliance
  • Prepare all necessary documents for inspection and ensure the facility, equipment, and processes are compliant with regulatory guidelines
  • Manage the Quality Management System, including deviations, CAPA, change control, and standard operating procedures (SOPs)
  • Provide technical support for customer enquiries and complaint investigations
  • Investigate product complaints and generate investigation reports
  • Act as a key person for pharmacovigilance queries in the absence of the Quality Manager
  • Assist in the coordination and performance of internal quality audits
  • Lead preparation activities and be responsible for backroom activities during external/customer audits
  • Deputy for the Quality Manager as and when required
  • Vendor qualification of suppliers in line with internal processes
  • Process validation, cleaning validation, and transport validation, equipment and utility qualification
  • Lead the review, approval, and release of SOPs, Instructions, Forms, Batch Production Records, and testing data
  • Coach and mentor team members on quality assurance and business requirements

**Requirements:**

  • Proven experience in a Quality driven role in Pharmaceuticals with a good understanding of UK regulatory market
  • Experience of managing a quality team highly desirable
  • Degree (or equivalent) in a Scientific discipline
  • Good understanding of manufacturing drug substances (ideally including herbal products)
  • Good understanding of good agriculture and collection practices
  • Proficient in MS Office
  • Excellent communication skills (verbal and written)
  • A good eye for detail and ability to meet strict deadlines

**How to Apply:** Please submit your CV with a covering letter.