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Audit and Quality Assurance Officer

2 months ago


Manchester, United Kingdom SRG Full time

Job Title: Quality Assurance Officer

Type: Permanent

Salary: Highly attractive with great benefits

Location: Northwest, England

SRG is currently working exclusively with a highly successful, award-winning, contract development and manufacturing organisation, focused on providing expert intelligence and support to their partners, driven by their capabilities.

As a result of expansion into a new state-of-the-art facility, we are looking for a Quality Assurance Officer to join their quality team and be a key member of the QA function.

Key Responsibilities:

  • Manage documentation through the documents lifecycle, ensuring compliance with regulations and industry best practices.
  • Creating, reviewing, and approving key documentation such as specifications, SOPs, protocols, and methods associated with a product.
  • QA review and dossier collation of GMP production and analytical documentation prior to QP release.
  • Investigating and addressing deviations to prevent future occurrences.
  • Managing supplier suitability and any issues and supplier mitigation steps for supplier complaints raised.
  • Proactively able to identify and manage site improvements for Quality Improvement through CAPAs.
  • Ensure training on procedures (SOPs) is up-to-date and in line with industry standards. Prepare and conduct quality training sessions, including induction and GMP training.

Essential Requirements:

  • Minimum of 1 year's experience in Quality Assurance within a Pharmaceutical (GMP) facility, preferably Investigational Medicinal Products (IMPs).
  • Degree in a relevant scientific discipline desired.
  • Experience in working with analytical laboratories and GMP production areas.
  • An understanding of GMP and regulatory requirements within the pharmaceutical industry.