Quality Assurance Specialist

Quality Assurance Specialist - Global Pharmaceutical Company

Contract: 12-Month Contract

Location: Dublin, Ireland

Salary: 96,700 per annum

SRG are working with a Global Consumer Pharmaceutical company to help them find a Quality Assurance Specialist to join their busy team.

The Quality Assurance (QA) Specialist will be an active member of the ADL Disposition Team and will serve as the Quality reviewer and approver on GMP documentation. The QA Specialist will report to the Associate Director and will be required to be a Subject Matter Expert in their assigned area of responsibility. QA specialists will be required to understand and grasp a broad range of quality related competencies.

Key Responsibilities will include:

• Participation in self-inspection program in a lead auditor or auditor capacity
• Quality Risk Management execution/facilitation
• Provision of QA Subject Matter Expertise for complex investigations and associated CAPAs, as required.
• Inspection readiness activities and hosting of internal and external Board of Health inspections, inclusive of providing QA technical expertise during audits/inspections
• Metric reporting, monitoring and representing the Quality Assurance function at cross-functional meetings and external forums.
• Provision of Quality Oversight and partnership for internal and external customers
• Assuming site or business process owner roles, and active participation at network meetings and external forums
• In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
• 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.

Candidate Requirements:

• University degree in Science or Engineering related discipline.
• Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
• Root Cause Analysis / Deviation investigations
• Experience with Regulatory inspections / Regulatory Documentation concerning compliance. This will be around liaising with inspect with regulatory agencies in respect to updating licences or site Masterfile. Doesn't have to be the F2F inspection.
• Experience working in aseptic operations, protein formulation, vial and syringe filling, labelling/packaging operations. Protein end more preferred due to the incoming component end as you've got no product there. They're nude components - their unfilled and haven't gone onto the manufacturing site as of yet.
• Good eye for detail as they're reviewing and they're the inspecting those incoming components and making sure that they're fit or purpose for use in their lines. Able to follow through, someone with a QC background, is generally quite good because they follow methods, they follow specifications, and that's what their incoming materials are inspected against in Amgen. It's very much specification and the methods used to perform the testing as part of that specification. Those usually have experience at that end usually pick it up quite quickly for the incoming components.
• The team use Track Wise (deviation system) and SAP.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.