Quality Assurance Expert

Quality Assurance Expert - Pomezia (Near Rome, Lazio)

An excellent opportunity to join a leading manufacturer who are seeking a Quality Assurance expert. You’ll play a crucial role in ensuring and promoting a companywide quality system aligned with current Good Manufacturing Practices (GMP) regulations.

Our client is a major player in their field in terms of research and development and innovation.

Role responsibilities:

• Ensure analysis and processing of procedures, technical documents, and other internal documentation.
• Develop, issue, approve, and update master batch records of experimental medicinal products, ensuring compliance with Product Specification Files of experimental medicinal products, current GMP regulations, safety and quality standards, and planned timelines.
• Perform batch record review of all batches produced, ensuring compliance with current GMP regulations.
• Review documents generated by the Plant and R&D Quality Control (e.g., logbooks, records, protocols, test methods, specifications, etc.).
• Review trends of critical parameters of plant utilities.
• Ensure necessary initial and ongoing training of personnel is conducted as needed.
• Ensure GMP documentation is archived properly.
• Manage deviations, complaints, and withdrawals in accordance with approved procedures, identifying possible root causes and evaluating their impact on product quality.
• Issue and approve action plans following observations made during Regulatory Authority and/or client inspections, and monitor their implementation.

The ideal candidate

• Previous experience in a quality assurance role within a chemical/pharmaceutical manufacturing environment.
• Knowledge of GMP standards, manufacturing and packaging processes.
• Experience of preparing, conducting and managing inspections.
• Fluent in Italian and English.

On Offer

Generous remuneration and benefits package . Negotiable depending on experience.

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