Quality Assurance Specialist

6 days ago

Barnard Castle, United Kingdom GlaxoSmithKline Full time

About the Role:

We are seeking a highly skilled Quality Assurance Specialist to join our team at GlaxoSmithKline. As a key member of our quality management team, you will be responsible for ensuring the highest standards of quality in our manufacturing processes.

Key Responsibilities:

  • Manage and maintain systems used to release starting materials for finished products.
  • Provide expert advice on supplier changes, vendor complaints, and Corrective and Preventative Actions (CAPA).
  • Monitor the Supplier Quality Workflow and create and review Raw Material Specifications.
  • Oversight of new Active Pharmaceutical Ingredients (API)/Raw Materials, raising Change Controls in VQMS and allocating actions.
  • 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.
  • 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 the 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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