APS & Sterility Specialist

Work Schedule Standard ( Mon- Fri) Environmental Conditions Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. . . allowed, Office Job Description What Makes This Opportunity Unique At Thermo Fisher Scientific Inc. , 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.
What will you do? Develop and issue APS protocols and reports for manufacturing sterile lyophilized and liquid drug products.
Adhere to GMP and corporate standards, including modern pharmaceutical technologies like fill-finish processes under isolators.
Issue manufacturing instructions for APS runs to ensure execution of production processes.
Issue technical reports and risk assessments pertaining to operator qualification, qualified holding times, and aseptic interventions.
Ensure appropriate management and archiving of documentation in line with GMP and internal procedures.
Coordinate manufacturing activities to ensure strict compliance with established protocols.
Support in the preparation and update of APS department Standard Operating Procedures (SO Ps).
Ensure all relevant activities are assessed and led through change control management.
Participate in clients' and regulatory audits concerning APS activities.
Support our client service delivery performance at the highest level by feeding positive relationships with clients and ensuring timely coordination and communication.
Provide adequate reporting to Area Management about potential issues to maintain seamless operations.
How will you get here? Educational Background: Degree in Pharmacy, CTF, Biological Sciences, Chemistry, Industrial Chemistry, Chemical Engineering, or Biotechnology.
Industry Experience: At least 2-3 years of experience in the pharmaceutical or chemistry industry.
Knowledge, Skills, Abilities Language Proficiency: Proficient in English and Italian.
Sterility Assurance: Proven knowledge of sterility assurance concepts.
Pharmaceutical Legislation: Familiarity with pharmaceutical legislation and national/international laws.
Social Skills: Excellent interpersonal skills and a demonstrated ability to work effectively in a team.
Technical Documentation: Strong propension towards the preparation of technical documentation.
Attention to Detail: Remarkable attention to detail and precision.
Organizational Skills: Outstanding ability to efficiently manage and complete multiple tasks.
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