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Details

QA Specialist


Reference:SMC035309 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Specialist, QA Engineer

Summary

We’re currently recruiting for an exciting opportunity with an award winning Pharmaceutical organization based in Cork. 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.


Duties

• Supports GMP activities from operational through to Laboratory support programs.
• Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained.
• Responsible for implementation of systems and procedures for the management of change control and deviation management, as it applies to plant installations, systems, and operations in accordance with GMP.
• Quality oversight of project activities including but not limited to, C&Q activities and process validation through to commercial manufacture.
• Participates as a key quality member in inspections and audits of JSCI by external parties/agencies.
• Key participant within the QA team in the execution of their duties.
• Executes the activities of the group within quality to create a synergistic approach to goals and tasks.
• Domestic and international travel may be required.


Education & Experience


• Bachelors Degree in a scientific/technical discipline required
• Experience required in a quality or compliance role within the biological and/or pharmaceutical industry.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
• Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
Desirable
• Advanced degree (MS, MBA, PhD) preferred
• Experience in C&Q, and Process validation
• Experience in direct interactions with regulatory agencies during site inspections.


If you would like further Information you can contact the recruiter directly:

Sean McCarthy | Tel: +353 (0) 87 798 8480