QA Associate

Summary:

Our client has a unique opportunity for a QA Associate to join the team in a large biopharmaceutical company. If you are someone who wants to be part of an organisation that brings life-changing medicines to those who need them, this could be the career step for you!

Responsibilities:

• Provide Quality input and guidance to ensure Lot Release (Drug Substance and Final Packed Finished Product) of high-quality products in compliance with current Good Manufacturing Practices (GMPs).
• Compilation of Lot Release Packs as per requirements of SOPs, WIs and related FRMs.
• Provide Quality direction and oversight of the development and continuous improvement of new and existing processes/systems to meet customer needs.
• Provide Quality input to Change Control/Deviations ensuring scope of record is clear and implementation activities are robust and timely. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
• Participation in and leading internal inspections in the Lot Release area of operations.
• Prepare reports for Product Quality Reviews including batch listing and deviation trend reports to ensure that trends are acted upon and to demonstrate that products consistently meet desired critical quality attributes.

Requirements:

• Degree or 3rd level qualification (Science, Quality).
• Demonstrated experience in Lot Release and Packaging as the Quality contact for the area.
• Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role.
• Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems.
• Excellent written and verbal communication skills.
• Demonstrated ability in problem-solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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