We’re currently recruiting for an exciting opportunity with an award winning pharmaceutical organization based in Dublin. This is an excellent opening for anyone who is looking to join a leading multinational who are one of the best at what they do.
The Senior Quality Assurance Specialist will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility. QA TS Specialist will be required to understand and grasp a broad range of quality related competencies.
• Provide overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory expectations.
• Act as Quality point of contact and decision maker during New Product Introductions, Technology
• Review and approve validation lifecycle documents, including Master-plans, protocols, reports and active participation during earlier phases of process design, Characterisation, Commissioning etc.
• Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
• Write, review and approve Standard Operating Procedures in accordance with company policies.
• Review and approval of Master Batch Records and SAP BOMS
• Quality SME reviewers/approvers for regulatory submissions, ensuring compliance with site and corporate procedures.
• University degree. Engineering or Science related discipline preferred.
• Relevant experience working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
• Experience working in aseptic operations, protein formulation, vial and syringe filling.
• Experience working in QA Technical Support or validation functions, including experience of New Product Introductions, Technology Transfer and Process Validation activities
• Experience working with dynamic cross-functional teams and proven abilities in problem solving and decision making
• Strong organizational skills, including ability to follow assignments through to completion
• Detailed Knowledge of applicable Regulatory requirements and experience with Regulatory inspections.
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480