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Analytical Development & GMP Documentation Specialist

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Thermo Fisher Scientific

8d ago

  • Job
    Full-time
    Mid & Senior Level
  • Science
    Research & Development

AI generated summary

  • You must have a degree in chemical engineering/chemistry, GMP experience, English and Italian skills, strong organization, teamwork, and communication abilities.
  • You will manage analytical documentation, collaborate with stakeholders, provide compliance consulting, oversee key projects, address OOS/OOT issues, and perform laboratory investigations and CAPA management.

Requirements

  • Bachelor's degree in chemical engineering, chemistry, or equivalent work experience with pharmaceutical companies.
  • GMP standards applied to Quality Control laboratories, with particular reference to stability studies, laboratory data management and SOP writing.
  • English and Italian
  • Flexibility and adaptability.
  • Good organization and planning skills
  • Excellent listening, oral, and written communication skills
  • Ability to work in a team

Responsibilities

  • Responsible for the analytical documentation of APIs, Excipients and DP (release and stability tests).
  • Collaborate with Clients, QC PDS, Regulatory Department, QC Compliance, QA and QO in order to issue the correct documents for PDS projects, respecting the ICH and Pharmacopoeia.
  • Provide compliance consulting and strategic advice to internal and external clients to determine the most appropriate approach in order to have compliant documentation for their products.
  • Provide project specific strategy, technical expertise in QC Documentation matter and coordination oversight for key client’s projects.
  • Serve as the executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public relation functions. Ensures quality performance for key/managed projects.
  • Responsible for the evaluation of OOS, OOT and laboratory investigation in terms of recurrences, root cause, trend and define CAPAs.
  • Perform laboratory investigations, laboratory OOS and OOT and any deviations and CAPA related to them Collaborating with Supervisor and Team Leader to manage these.

FAQs

What is the main responsibility of the Analytical Development & GMP Documentation Specialist?

The main responsibility is to manage all documentation related to assigned projects, including OOS/OOT/Change control, SOPs, and CoA, ensuring successful project continuation within the PDS.

What qualifications are required for this position?

A Bachelor's degree in chemical engineering, chemistry, or equivalent work experience with pharmaceutical companies is required.

What languages are necessary for the role?

Proficiency in both English and Italian is necessary for this position.

Who does the Analytical Development & GMP Documentation Specialist report to?

The Specialist reports to the PDS AD&GMP Supervisor.

What kind of compliance knowledge is needed for this role?

Knowledge of GMP standards applied to Quality Control laboratories, especially in stability studies, laboratory data management, and SOP writing is required.

Is collaboration with other departments important in this role?

Yes, collaboration with Clients, QC PDS, Regulatory Department, QC Compliance, QA, and QO is essential to issue the correct documents for PDS projects.

What are some key skills needed for success in this position?

Key skills include flexibility, adaptability, good organization and planning skills, excellent communication skills, and the ability to work in a team.

What type of investigations will the Specialist be responsible for?

The Specialist will be responsible for evaluating OOS, OOT, and laboratory investigations, including identifying recurrences, root causes, trends, and defining CAPAs.

What is the significance of the Monza site in Thermo Fisher Scientific?

The Monza site offers compliance with controlled drug regulations in Europe and the U.S., provides manufacturing technologies, and supplies products to over 20 countries, including major international markets.

What is the company’s mission?

Thermo Fisher Scientific's mission is to enable customers to make the world healthier, cleaner, and safer.

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.