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Details

Quality Assurance Specialist


Reference:SMC05936 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Quality Assurance Officer

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. This role within the QA Quality Systems and Monitoring team is an advanced position requiring the successful candidate to have significant experience as a QA professional supporting electronic system introduction and upgrades within a GMP environment.

Duties
• Perform as the QA representative for all stages of two automation projects, supporting qualification and validation activities as per project timelines in accordance with site procedures and GMP guidelines
• Provide QA advice and support to the project teams as required to ensure compliance with applicable regulatory requirements
• Participates in developing and approving SOPs to ensure quality objectives are met
• May conduct or serve as lead of investigations and CAPA recommendations related to manufactured products
• Develops solutions to more complex problems and identifies deviations from accepted practices and evaluates impact assessment as required
• Normally receives no instruction on routine work and general instructions on new assignments.

Experience
• Demonstrates proficiency in GMPs
• Demonstrates proficiency in the application of QA principles, concepts, industry practices and standards
• Demonstrates thorough knowledge of FDA and EMA standards and quality systems and interfaces with other site functions
• Demonstrates strong knowledge of six sigma and root cause analysis tools used for identifying and correcting deviations
•Prior experiences in a pharmaceutical industry is preferred, guideline of 6+ years in relevant field with appropriate BS or BA qualification.




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

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