Pharmaceutical Sterility Specialist
3 settimane fa
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed,
Office
What Makes This Opportunity Unique
At Thermo Fisher Scientific, we provide a highly collaborative and multifaceted environment where you can excel and make a meaningful difference in the world.
Join Our APS & Sterility Team and work alongside top-tier experts committed to achieving our mission flawlessly.
In this role, you have the chance to define and implement standard methodologies, playing a vital role in establishing our position as a pharmaceutical industry leader.
Key Responsibilities
1. Develop and issue APS protocols and reports for manufacturing sterile lyophilized and liquid drug products.
2. Adhere to GMP and corporate standards, including modern pharmaceutical technologies like fill-finish processes under isolators.
3. Issue manufacturing instructions for APS runs to ensure execution of production processes.
4. Issue technical reports and risk assessments pertaining to operator qualification, qualified holding times, and aseptic interventions.
5. Ensure appropriate management and archiving of documentation in line with GMP and internal procedures.
6. Coordinate manufacturing activities to ensure strict compliance with established protocols.
7. Support in the preparation and update of APS department Standard Operating Procedures (SOPs).
8. Ensure all relevant activities are assessed and led through change control management.
9. Participate in clients' and regulatory audits concerning APS activities.
10. Support our client service delivery performance at the highest level by feeding positive relationships with clients and ensuring timely coordination and communication.
11. Provide adequate reporting to Area Management about potential issues to maintain seamless operations.
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