QA Specialist

Description

Role - QA Specialist

Location - Co. Carlow, Ireland
Type - initially 6 month contract

One of our key global Pharmaceutical clients are looking for a QA Specialist to support day to day QA activities in the site facility and participate as a core member of the Process Team that manages Vaccine and Biological product manufacture/as a member of the Quality Centre of Excellence (CoE) or as a member of the Quality New Product Introduction team.

Key Responsibilities-
Participate in process reviews as the Quality Assurance representative, ensuring quality issues are identified, addressed and resolved before production commences.
QA review and approval of postproduction process batch for validated steps prior to release of material by Quality.
Provide positive feedback on re-occurring issues thus ensuring continuous improvement to the system.
Carry out QA review and approval of the postproduction cleaning records for validation steps prior to release of material by Quality.
Provide support to deviation investigations and process performance monitoring on a daily basis.
Attend cleaning meeting, review any cleaning investigations and ensure corrective actions are closed out.
Prepare & coordinate the review & approval of the Annual Product Review Schedule.
Prepare annual process reviews for intermediates and finished bulk products as determined by the Annual Product Review (APR) Schedule.
Review and verify Company documentation that may be used for submission to RAS-CMC or other requester(s) for regulatory submissions/filings.
Support the introduction of new products onto site in relation to Quality oversight, covering the end to end strategy.
Participate in the Product Core Team meetings and facilitate the Quality Sub Team meeting. Authors, reviews and participates in approvals of protocols and reports for technology transfer, method qualifications and method validation.
Performs quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
Act as lead auditor to support the internal GMP audit schedule including preparation & approval of the internal schedule and the external suppliers audit schedule.
Complete vendor audits as requested by the Divisional Audit group & aid in specific queries in relation to company related materials.
Carry out induction GMP and compliance training for new employees, laboratory and plant personnel
Act as lead auditor to support and manage the internal GMP audit schedule and the external suppliers audit schedule.