02 ago - Medolla
Experteer Italy
Experteer Overview
As Quality Manager at Phibro Medolla, you lead QA and compliance to safeguard product quality across the commercial supply. You provide strategic QA guidance to operations, engineering, and supply chain, and drive deviation investigations and CAPA programs. You will oversee GMP document reviews, technology transfers, and NPIs, ensuring timely regulatory readiness and inspection support. Your work helps to sustain safe, compliant veterinary medicines and feed additives in a global business. This role offers impact by shaping quality systems and partner collaborations in a manufacturing setting.
Retribuzione / Benefits
- Provide strategic QA leadership for deviation investigations including root cause analysis and corrective/preventive actions.
- Lead QA review and approval of SOPs, batch records, validation protocols, and reports.
- Manage schedules for GMP document review/approval to meet commercial timelines.
- Support technology transfers and NPIs with QA processes and approvals.
- Support regulatory submissions and inspection readiness,
including leading audits and responding to observations.
- Coordinate supplier audits under PAHC Supplier Management/audit program and monitor CAPA follow-up.
- Develop QA department objectives, conduct performance reviews, and create development plans for staff.
- Ensure compliance with Safety, Health and Welfare at Work legislation and company policies.
Responsabilità
- Advanced degree in a technical discipline (Masters, PhD)
- Minimum 7 years' experience in a GMP Quality environment
- At least 3 years in a managerial role
- QP eligibility and experience releasing batches
- Desirable: 7 years' experience in pharmaceutical industry (preferably veterinary) and experience as named QP
- Experience leading regulatory audits and exposure to Health Authority inspections/audits
- Strong knowledge of EU GMP, ICH, HACCP, and veterinary feed additive regulations
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