**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 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 (SOPs).
- 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.
Join us!