APS & Sterility Specialist
APS & Sterility Specialist
Posted on :
04-09-2025
Employer Active
1 Vacancy
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed OfficeJob Description
What will you do
- 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.
How will you get here
- 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.
Knowledge Skills Abilities:
- 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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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