Quality Assurance Specialist

7 days ago

Skipton, North Yorkshire, United Kingdom Dechra Pharmaceuticals PLC Full time
About the Role

We are seeking a highly skilled Quality Operations Associate to join our team at Dechra Pharmaceuticals PLC. As a Quality Operations Associate, you will play a critical role in ensuring compliance to relevant SOPs and GMP standards, and delivery of site quality metrics.

Key Responsibilities
  • Perform In-Process Checks: Ensure Quality-based systems and procedures are followed within the operations functions, making decisions and recommendations on actions needed to resolve technical and GMP compliance issues.
  • Provide Guidance and Support: Offer guidance on operational changes and improvements, supporting internal and external quality/technical audits, and training new team members on current and emerging regulatory requirements.
  • Deliver Quality KPIs: Actively aid in the delivery of the QA KPIs, ensuring that GMP, Quality, batch-specific, and client requirements are being adhered to at all times within the Operations area.
  • Participate in CI Activities: Participate in Continuous Improvement activities and projects, challenging current working practices to improve efficiencies and Quality standards.
  • Prioritize Workload: Prioritize workload and ensure key quality issues and business priorities are addressed and escalated appropriately and resolved in a timely manner.
  • Assist in Quality Investigations: Assist in quality investigations and participate in incident meetings, verifying cGMP data entries into site computer systems.
  • Represent Quality: Participate in required site meetings as representatives of Quality when required, applying problem-solving capabilities to determine root causes of issues and identify effective CAPA to increase right-first-time and improve efficiencies and reduce operating costs.
  • Review Batch Documentation: Review batch documentation for adherence to cGMP compliance.
Requirements
  • Previous Experience: Must have previous experience of working in a GMP manufacturing environment.
  • Problem-Solving Skills: Experience and ability to drive issues through to a satisfactory conclusion.
  • Quality Knowledge: Previous experience of working in a Quality environment and knowledge of document systems and indexing are desirable.

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