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APS & Sterility Specialist

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Thermo Fisher Scientific

1mo ago

  • Job
    Full-time
    Junior & Mid Level
  • Research & Development
    Healthcare
  • Milan

AI generated summary

  • You need a relevant degree, 2-3 years in pharma/chemistry, English and Italian proficiency, knowledge of sterility assurance and legislation, excellent social skills, and strong attention to detail.
  • You will develop APS protocols, issue manufacturing instructions, manage documentation, coordinate compliance, support SOP updates, lead change control, participate in audits, and ensure client satisfaction.

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 are the work hours for the APS & Sterility Specialist position?

The work schedule is standard, Monday to Friday.

What are the environmental conditions for this role?

You will work in a cleanroom environment where no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair are allowed.

What is the primary industry focus of the APS & Sterility Specialist role?

The role focuses on the pharmaceutical industry, particularly in developing and issuing protocols for manufacturing sterile lyophilized and liquid drug products.

What is the minimum educational qualification required for this position?

A degree in Pharmacy, CTF, Biological Sciences, Chemistry, Industrial Chemistry, Chemical Engineering, or Biotechnology is required.

How much industry experience is needed to apply for this role?

At least 2-3 years of experience in the pharmaceutical or chemistry industry is required.

What languages are required for this role?

Proficiency in English and Italian is required.

What are some of the key responsibilities of the APS & Sterility Specialist?

Key responsibilities include developing APS protocols, coordinating manufacturing activities, issuing technical reports, and participating in client and regulatory audits.

What skills are essential for the APS & Sterility Specialist position?

Essential skills include knowledge of sterility assurance concepts, familiarity with pharmaceutical legislation, excellent interpersonal skills, strong attention to detail, and outstanding organizational skills.

Will there be support for professional development or training in this role?

Yes, the company provides a collaborative environment focusing on professional growth and development.

How does this role contribute to client service delivery?

The APS & Sterility Specialist ensures positive relationships with clients and timely coordination and communication to meet service delivery standards.

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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.