QA Specialist
CK Group are recruiting for a QA Specialist to join a biopharmaceutical company at their site based in Dun Laoghaire on a contract basis for 12 months.
Salary: From €30 per hour depending upon experience
QA Specialist Role:
- Perform all activities in compliance with company safety standards and SOP
- Provide Quality direction and input at Change Control and NC Review Boards and assume oversight of change control and NC/CAPA records; ensuring scope of record is clear and implementationactivities are robust and timely.
- Write, review and approve Standard Operating Procedures in accordance with company Policies.
- Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control) and provide active input into shaping the future direction of these systems.
Your Background:
- Hold a degree in Engineering or a Science related discipline or equivalent working knowledge
- Extensive working experience in the pharmaceutical or biotechnology industry
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
- Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.· Experience working in aseptic operations, protein formulation, vial and syringe filling.
Company: Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of humanhealthcare conditions from cancer to arthritis.
Location: This QA Specialist role will be based at our clients site in Dun Laoghaire, County Dublin
Apply: For more information, please contact Natasha on 01246 457739 or email irishcontracts@ckagroup.co.uk. Please quote reference 49624.