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APS & Sterility Specialist

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

AI generated summary

  • You need a degree in relevant sciences, 2-3 years in the pharma/chem industry, fluency in English and Italian, knowledge of sterility assurance and legislation, strong documentation skills, and excellent attention to detail.
  • You will develop APS protocols, issue manufacturing instructions, manage documentation, coordinate compliance, support SOP updates, 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 are the working hours for the APS & Sterility Specialist position?

The working hours for this position are standard, Monday to Friday.

What are the environmental conditions for this role?

The role involves working in a cleanroom environment where no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair are allowed, alongside office work.

What does the APS & Sterility team focus on?

The APS & Sterility team focuses on developing and implementing standard methodologies for manufacturing sterile lyophilized and liquid drug products in compliance with industry standards.

What qualifications are required for this position?

Candidates should possess a degree in Pharmacy, CTF, Biological Sciences, Chemistry, Industrial Chemistry, Chemical Engineering, or Biotechnology.

How much industry experience is necessary for applicants?

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

What languages should candidates be proficient in?

Proficiency in both English and Italian is required.

What skills are crucial for this role?

Key skills include knowledge of sterility assurance, familiarity with pharmaceutical legislation, excellent interpersonal skills, attention to detail, strong organizational skills, and a propensity for preparing technical documentation.

Will the specialist have to participate in audits?

Yes, the specialist will participate in clients' and regulatory audits concerning APS activities.

Is it necessary to prepare technical reports in this role?

Yes, the specialist will issue technical reports and risk assessments related to operator qualification and aseptic interventions.

How does this position support client service delivery?

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

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.