Quality Unit Director
Pharma Point
Milan
25
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Azienda: Pharma Point Milan
This role will be responsible for overseeing Quality Assurance and Quality Control (chemical and microbiological laboratories) ensuring full compliance with GMP and regulatory requirements.
Key Responsibilities:🔹 Develop and implement quality strategies to optimize manufacturing processes and maintaining compliance🔹 Ensure GMP compliance and adherence to international regulatory standards (FDA, EMA, AIFA, etc. )🔹 Act as the Qualified Person (QP)🔹 Lead and manage the team, fostering a culture of quality and continuous improvement and ensuring training programs🔹 Oversee batch release activities, deviations, CAPA, change controls, and risk assessments, ensuring timely resolution and documentation🔹 Lead internal and external audits, including regulatory inspections and customer audits, and drive audit readiness Requirements:✅ Bachelor' s or Master’s degree in Chemistry, Pharmaceutical Sciences, Biology, or a related field. ✅ Recognized QP eligibility under EU Directive 2001/83/EC✅ Proven experience in Quality Leadership roles within a pharmaceutical manufacturing environment. ✅ Strong knowledge of GMP, ICH guidelines, and regulatory requirements (FDA, EMA, AIFA)✅ Excellent leadership, decision-making, and problem-solving skills.
✔ Pharma Point
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