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QA Validation Specialist

Reference:SMC05932 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Validation Specialist


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.

• Acts as the day-to-day QA projevct contact person for the Manufacturing and Engineering departments providing guidance / feedback on quality issues related to their respective area project activities.
• Completes the review & approval of Manufacturing and Engineering project documentation - in particular equipment/ process/ automation validation documentation.
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
• Actively contributes to continuous improvement initiatives.
• Builds and maintains good working relationships with Engineering, Manufacturing and Quality department personnel in particular.
• Supports the preparation for regulatory and customer GMP inspections of the site in addition to performing and co-ordinating internal audits.
• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations to ensure they are implemented and accurately documented in a timely manner.
• Participates in developing Standard Operating Procedures (SOP’s) to ensure quality objectives are met.
• Participates in site cross-departmental teams as the QA representative - Attending associated meetings ensuring QA is represented & its concerns/ issues communicated, aiding in the identification of potential improvements and participating in discussions on issues/ queries on the associated systems/process.
• Assists with the maintenance of programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
• Ensures compliance with all site safety-related procedures and practices.

Qualifications & Experience
• Minimum of 4 years of relevant experience and a BSc or 2 years of relevant experience and a MSC.
• Prior experience in a cGMP related industry is desirable, within Biopharmaceutical or Pharmaceutical industry preferred.
• Experience in the review & approval of Validation documentation essential.
• Demonstrates proficient knowledge of FDA/EMA regulations, guidances and current Good Manufacturing Practices (GMPs).

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

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