QA Officer |Negotiable
Quality Assurance
Permanent
London

Compounding QA Release Officer

Additional Information

Location: Thetford

Salary: £28,000 – £35,000 plus benefits

Hours: 6am-2pm / 2pm – 10pm

Job Type: Permanent

Report to: Site Quality Assurance Manager

Summary

  • Ensure continuous compliance of Compounding Unit to cGMP and “Specials” manufacturing requirements, local procedural requirements and Baxter Corporate policies;
  • Execute documentation and batch reviews;
  • Support delivery of product release targets, including ensuring timely batch review activities and batch disposition of any deviations with impact to product release;
  • Support manufacture of aseptically products by making QA decisions during batch manufacturing and ensuring GMP is adhered to at all times;
  • Support Production in the review and post compounding check operations;
  • Proactively identify and support implementation of continuous improvement opportunities in QA and Production Operations;
  • Lead and support investigation of deviations and complaints;
  • Ensure timely completion of all Quality System commitments;
  • Ensure timely communication of significant GMP and product quality issues to QA Management;
  • Ensure compliance of Thetford Compounding Unit with cGMP and “Specials” manufacturing requirements, as well as regulatory and Baxter Corporate expectations;
  • Comply with EHS/GMP/GDP/company and corporate policies and external regulatory requirements;
  • Implement and sustain EMS principles.

Qualifications and experience required

Education

  • Science degree (e.g. Pharmacy, Chemistry, Biosciences) or relevant experience.

Skills and Experience

  • Must have QA (not QC) experience
  • Must have GMP experience (MHRA requirement)
  • Must have Pharma/science qualification – Btech or higher
  • Aseptic or clean room experience ideal

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