APS & Sterility Specialist
- Monza
- Tempo indeterminato
- Full time
- Analyze technical documentation.
- Evaluate APS protocols and reports per GMP and corporate standards for manufacturing sterile drug products.
- Review of manufacturing instructions (MBR) for APS runs.
- Issue or review technical reports and risk assessments related to operator qualification, qualified holding times, aseptic interventions.
- Ensure accurate management and archiving documentation in line with GMP and internal procedures.
- Coordinate manufacturing activities during APS exercises.
- Assist in developing and revising APS department SOPs.
- Ensure all relevant activities are adequately evaluated and managed through change control management.
- Assist in preparing for and engaging in client and regulatory audits related to APS operations.
- Maintain high-level client service delivery performance by fostering positive relationships with clients and coordinating activities to ensure timely communication.
- Provide adequate reporting to Area Management about potential issues.
- Degree in Pharmacy, CTF, Biological Sciences, Chemistry, Industrial Chemistry, Chemical Engineering, or Biotechnology.
- At least 2-3 years of experience in the pharma/chemistry industry.
- Proficient in English and Italian.
- Knowledge of sterility assurance concepts.
- Knowledge of pharmaceutical legislation and national/international laws.
- Good communication skills and partnership.
- Propensity to prepare technical documentation.
- Attention to details and precision.
- Organizational skills.