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Details

QA Specialist - Packaging


Reference:SMC06427 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Specialist

We’re currently recruiting for an exciting opportunity with an award winning pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements through support of Packaging and Engineering functions.
• Works directly with Packaging and Engineering functions to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
• Reviews routine Packaging and Engineering documents including tech trial protocols and reports
• Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to packaged products.
• Reviews and evaluates proposed changes, qualification and validation documentation as related to engineering and manufacturing.
• May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.
• May assist with compliance audits as required.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
• Participates in developing Standard Operating Procedures and writes and/or implements changes to controlled documents to ensure quality objectives are met.
• Normally receives no instruction on routine work, general instructions on new assignments.

Education and Experience


• Relevant experience in a GMP environment related field and a BS, BA or MS.
• Prior experience in pharmaceutical industry is preferred.


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

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