Sterility Assurance Specialist

2 giorni fa

Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
Work Schedule Standard

Environmental Conditions:

Our cleanroom environment requires adherence to strict guidelines, including prohibition on hair products, jewelry, makeup, nail polish, perfume, and exposed piercings.

Job Description:

We are seeking a highly skilled Sterility Assurance Specialist to join our APS Sterility team at Thermo Fisher Scientific Inc.

What Makes This Opportunity Unique:

At Thermo Fisher Scientific Inc., we foster a collaborative and multifaceted environment where you can excel and make a meaningful difference in the world.

Key Responsibilities:

  1. Develop and issue APS protocols and reports for manufacturing sterile lyophilized and liquid drug products.
  2. Ensure adherence 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. Manage and archive documentation in line with GMP and internal procedures.
  6. Coordinate manufacturing activities to ensure strict compliance with established protocols.
  7. Support the preparation and update of APS department Standard Operating Procedures (SOPs).
  8. Lead change control management and participate in clients' and regulatory audits concerning APS activities.
  9. Support client service delivery performance by maintaining positive relationships with clients and ensuring timely coordination and communication.
  10. Provide reporting to Area Management about potential issues to maintain seamless operations.

Requirements:

  1. Educational Background: Degree in Pharmacy, CTF, Biological Sciences, Chemistry, Industrial Chemistry, Chemical Engineering, or Biotechnology.
  2. Industry Experience: At least 2-3 years of experience in the pharmaceutical or chemistry industry.
  3. Language Proficiency: Proficient in English and Italian.
  4. Sterility Assurance: Proven knowledge of sterility assurance concepts.
  5. Pharmaceutical Legislation: Familiarity with pharmaceutical legislation and national/international laws.
  6. Social Skills: Excellent interpersonal skills and a demonstrated ability to work effectively in a team.
  7. Technical Documentation: Strong inclination towards the preparation of technical documentation.
  8. Attention to Detail: Remarkable attention to detail and precision.
  9. Organizational Skills: Outstanding ability to efficiently manage and complete multiple tasks.

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