Quality Oversight Specialist for Production

Join the Quality team at the Brindisi site to work on GMP tasks "on the shop floor". You will promote a culture of respect for cGMP in production departments and collaborate closely with them to identify and implement actions aimed at improving and simplifying activities, always in full compliance with GMP, regulatory, and business requirements.

Your Responsibilities

1. Verify the completion of departmental documentation such as logbooks, annexes, procedures, laboratory records, warehouse documentation, packaging, technical services, BPR, and checklists related to production oversight.
2. Identify non-compliance, suspected non-compliance, improvements, and best practices in GxP activities on the shop floor; coach personnel involved in GxP activities.
3. Identify gaps in documentation and inform quality assurance and department supervisors to review documents accordingly.
4. Ensure deviations are correctly reported in batch records; highlight behavioral issues and communicate acceptable and unacceptable behaviors, understanding different perspectives.
5. Verify proper cleaning, maintenance, and housekeeping of areas; examine relevant documents including registration dossiers, process validation reports, MBPR, analytical specifications, batch records, deviation trends, complaints, and stability data.
6. Interact with the Phenix system based on your profile (e.g., Event Creator, Investigation Leader, QA Expert, CAPA Leader, Efficiency Reviewer).
7. Investigate production quality concerns such as deviations, OOS, and OOT; implement improvement actions (CAPAs).
8. Periodically report key quality indicators; participate in change control activities as needed; review SOPs and provide training; support internal audits and participate in inspections by health authorities and customer audits.

Our Company

EUROAPI focuses on active ingredient solutions to meet global customer and patient needs. We are a leading pharmaceutical ingredients company with around 200 products, developing innovative molecules through our CDMO activities. Our Italy facility in Brindisi, established in 1966, specializes in GMP production of APIs including antibiotics and corticosteroids via large-scale fermentation.

Our Requirements

• Previous GMP experience in quality, quality control, or manufacturing.
• Good knowledge of GMP principles.
• Problem recognition and management skills.
• Accurate and meaningful reporting abilities.
• Proficiency in English.
• Strong communication skills for interaction with operators and technicians involved in GMP processes.

Your Benefits

• Competitive salary.
• Annual bonus.
• Company canteen.
• Training and development opportunities.
• Culture and values at EUROAPI, emphasizing career growth, talent management, and a respectful, inclusive work environment.
• Commitment to diversity, inclusion, sustainability, and resilience in the pharmaceutical supply chain.