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APS & Sterility Specialist

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Thermo Fisher Scientific

1mo ago

  • Job
    Full-time
    Junior & Mid Level
  • Science
    Healthcare
  • Milan

AI generated summary

  • You need a degree in relevant fields, 2-3 years in the industry, fluency in English and Italian, sterility knowledge, familiarity with legislation, strong documentation skills, and attention to detail.
  • You will develop APS protocols, issue manufacturing instructions, manage documentation, coordinate compliance, update SOPs, participate in audits, and maintain client relationships for seamless operations.

Requirements

  • 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.
  • 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.

Responsibilities

  • 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.

FAQs

What is the work schedule for the APS & Sterility Specialist position?

The work schedule is standard, Monday through Friday.

What environmental conditions should I be aware of for this role?

The role requires working in a cleanroom environment where hair products, jewelry, makeup, nail polish, perfume, exposed piercings, and facial hair are not allowed.

What is the primary responsibility of an APS & Sterility Specialist?

The primary responsibility includes developing and issuing APS protocols and reports for manufacturing sterile lyophilized and liquid drug products while adhering to GMP and corporate standards.

What qualifications are required for this position?

Candidates should have a degree in Pharmacy, CTF, Biological Sciences, Chemistry, Industrial Chemistry, Chemical Engineering, or Biotechnology, along with at least 2-3 years of experience in the pharmaceutical or chemistry industry.

Are knowledge of sterility assurance concepts and pharmaceutical legislation important for this job?

Yes, proven knowledge of sterility assurance concepts and familiarity with pharmaceutical legislation and national/international laws are critical for this role.

Is proficiency in languages required for this position?

Yes, proficiency in both English and Italian is required.

What skills are essential for success in this role?

Essential skills include excellent interpersonal skills, strong attention to detail, outstanding organizational skills, and a propensity for preparing technical documentation.

How does this position support client service delivery performance?

The role involves maintaining positive relationships with clients and ensuring timely coordination and communication to support high-level client service delivery performance.

Will I be involved in audits concerning APS activities?

Yes, you will participate in clients' and regulatory audits related to APS activities.

What is the role of change control management in this position?

Change control management is important to ensure that all relevant activities are assessed and led through proper procedures in line with GMP and internal processes.

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Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.