Quality Assurance Manager

4 weeks ago


Barnard Castle, United Kingdom GlaxoSmithKline Full time

GSK is seeking a Quality Assurance Manager to oversee the release of starting materials for finished products. This role involves managing systems, providing expert advice on supplier changes, and creating Raw Material Specifications.

Key Responsibilities:

  • Oversight of new Active Pharmaceutical Ingredients (API)/Raw Materials, ensuring the Supplier is suitable and material specifications are created.
  • Annual updates of Supply Chain Management (SCM) documents containing all Suppliers of materials for a given product.
  • Active management of Vendor Complaints, working closely with suppliers to ensure appropriate actions are progressed.
  • Raising, managing, and completing Change Controls for progression of new and existing excipients and non-GSK API testing requirements against pharma/regulatory standards.
  • Checks on the Supplier of a Packaging or Raw Material to ensure they meet expected quality standards.
  • Creating and approving Certificate of Analysis (C of A) acceptance reports to allow material deliveries to be accepted.
  • Review and update Distribution Risk Assessment (DRA) as required, assessing transportation to site from the Supplier ensuring compliance.
  • Reviewing quality systems in place for Suppliers not within scope of the audit process by performing desktop audits and generating subsequent reports.
  • Creating and reviewing agreements between Suppliers and site for specifications and purchase requirements.
  • Ensuring all Suppliers have been audited in accordance with expected frequency, reviewing audits performed, and ensuring reports are in line with site requirements.

Requirements:

  • Degree in Science related discipline or equivalent experience.
  • Ability to approach and discuss scientific data.
  • Strong communications skills, able to communicate at all levels internally and externally.
  • Experience using various electronic systems, e.g., SAP.
  • Good attention to detail, able to multitask.


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