Overview
The Quality Assurance Operations Manager is responsible for implementing, maintaining, and continuously improving the Pharmaceutical Quality System (PQS) at a veterinary vaccine manufacturing site, ensuring full compliance with GMP requirements and BI AH global quality standards. The role ensures that all quality systems, operational processes, and manufactured or distributed products remain in a state of control.
Responsibilities
* Ensure implementation, maintenance, and continuous improvement of Quality Systems in alignment with GMP (Eudralex Vol. 4, Annex 1, 2, 11) and quality guidelines.
* Maintain and promote a strong Quality Culture by ensuring an effective QMS across the site.
* Ensure compliance with cGMP, local regulations, and Corporate Quality requirements.
* Guarantee Data Integrity compliance and act as interface for computer system management and validation.
* Review and approve Master Batch Records, specifications, and key GxP documents; ensure documentation accuracy, compliance, and data integrity.
* Participate in internal and regulatory audits and inspections, providing documentation support and subject matter expertise; uphold high standards of traceability and completeness.
* Manage deviations, CAPAs, and change controls in alignment with GMP and Corporate procedures.
* Oversee root‑cause analysis and complaint investigations; support GMP‑relevant projects; act as Self‑Inspection System Owner; ensure timely batch record review; maintain inspection readiness.
* Ensure compliance with internal procedures, safety (D.Lgs. 81/2008), environmental and biosafety requirements and promote a quality, safety, and biosafety culture.
Requirements
* Education: Degree in Pharmacy, Biotechnology, Chemistry, Biology, Veterinary Medicine, or another relevant Life Science discipline.
* Qualification as Qualified Person (QP) highly preferred.
* Minimum 5–7 years of experience in Quality Assurance within the pharmaceutical, biopharmaceutical, or veterinary vaccine industry.
* Experience managing QA teams: experience leading QA teams and supporting QA Operations on the shopfloor is highly preferred.
Technical Knowledge
* Strong knowledge of EU GMP guidelines and relevant Annexes, quality systems, and operational compliance requirements.
Expertise
* Experience with deviation investigations, CAPA management, change control, risk management, data integrity, and batch record review.
* Familiarity with global corporate quality systems and digital quality tools.
Skills
* Excellent leadership, communication, and stakeholder‑management abilities.
* Strong analytical and problem‑solving skills with a risk‑based approach.
Languages
* Fluent in English and Italian (spoken and written).
Benefits
* Permanent contract.
* Free access to the company canteen.
* A range of benefits for your physical, financial, social and mental wellbeing.
* Support to develop your own professional and personal path through our development programs.
We warmly welcome applications from candidates belonging to protected categories, in accordance with Law 68/99. We foster a workplace built on respect, trust, and empathy—free from discrimination.
Quality Assurance Operations Manager • Noventa, Veneto, IT
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