QUALITY MANAGER
Role Purpose
The Qualified Person (QP) is responsible for ensuring that medicinal products are manufactured, tested, certified, and released in full compliance with applicable GMP regulations and regulatory requirements. The role acts as a key quality representative within the site, fostering a strong quality culture while balancing compliance and operational needs.
Key Responsibilities
- Perform batch certification and release in accordance with applicable pharmaceutical regulations.
- Ensure ongoing GMP compliance across manufacturing and quality operations.
- Review and manage deviations, non-conformances, CAPAs, and customer complaints.
- Support and participate in internal, external, and supplier audits.
- Collaborate closely with Quality Assurance, Quality Control, Manufacturing, and Site Leadership teams.
- Lead interactions with regulatory authorities during inspections, including AIFA and other health authorities.
- Promote continuous improvement initiatives related to quality systems and regulatory compliance.
- Provide guidance and influence decision-making to ensure an appropriate balance between operational requirements and compliance obligations.
Required Qualifications
- Valid AIFA Qualified Person Eligibility Certificate.
- Degree in Pharmacy, Chemistry, Pharmaceutical Chemistry and Technology (CTF), or a related scientific discipline.
- Registration with the Order of Chemists or Pharmaceutical Chemists and Technologists (may be completed after joining the company).
Required Experience
- 7-10 years of experience within the pharmaceutical industry.
- Experience working in GMP-regulated manufacturing sites.
- Strong background in Quality Assurance, Quality Control, Regulatory Affairs, or Compliance functions.
- Proven experience managing supplier audits, deviations, non-conformances, CAPAs, and complaints.
- Experience within API (Active Pharmaceutical Ingredient) environments is considered highly relevant and valuable.
Key Competenc
📌 Quality Manager (Verona)
🏢 Ecolab
📍 Verona