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Details

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

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
• 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