APS & Sterility Specialist
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Job Location:
Monthly Salary:
Posted on:
04-09-2025
Vacancies:
1 Vacancy
Job Summary
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
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
