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QA Deviations & Client Specialist - Pharmaceutical Development

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Thermo Fisher Scientific

11d ago

  • Job
    Full-time
    Mid & Senior Level
  • Milan

AI generated summary

  • You need a degree in Chemistry/Biological Sciences, multi-year QA experience, GMP knowledge, strong documentation skills, problem-solving abilities, and fluency in Italian and English.
  • You will review batch records, manage deviations and complaints, support client meetings, ensure quality objectives, respond to inquiries, and conduct training for Quality activities.

Requirements

  • Degree in Chemistry/ CTF/ Biological Sciences or similar fields
  • Multi-year experience in Quality Assurance Operations teams, with a focus on deviation management and support to GMP manufacturing
  • Excellent knowledge of GMP and national/international regulations
  • Ability to write, handle and review GMP documentation (Quality Agreement, CAPA…) and understanding of main quality indicators such as RFT (Right First Time) and OTD (On-Time Delivery).
  • Good problem-solving abilities, excellent communication and team working skills and ability to prioritize under time constraints
  • Italian and English

Responsibilities

  • Review Master Batch Records, perform Batch Record Review and generate supporting documentation for batch release
  • Review and manage deviations, investigations and complaints, in collaborations with all relevant functions
  • Support the organization of technical and managerial meetings with clients and participate in customer visits and audits by customers and/or regulatory authorities
  • Contribute to achieving "zero past due" objectives in Quality (CAPA, Complaints, Deviations) within one's scope of responsibility, as well as RFT (Right First Time) and OTD (On-Time Delivery) objectives for document submission to the client and lot release
  • Provide quality support to customers by responding to inquiries
  • Conduct training for personnel involved in Quality activities for PDS

FAQs

What is the primary focus of the QA Deviations & Client Specialist role?

The primary focus is to support the Pharmaceutical Development Service Unit in ensuring quality operations related to the manufacturing of clinical trial batches of sterile injectable products.

What qualifications are required for this position?

A degree in Chemistry, CTF, Biological Sciences, or similar fields is required, along with multi-year experience in Quality Assurance Operations teams and a strong understanding of GMP regulations.

What responsibilities will I have in this role?

Responsibilities include reviewing Master Batch Records, managing deviations and complaints, supporting client meetings and audits, ensuring quality objectives are met, and conducting training for personnel involved in Quality activities.

What languages are required for this position?

Fluency in both Italian and English is required for effective communication in this role.

How important is GMP knowledge for this position?

A strong knowledge of GMP and national/international regulations is essential for this role as it directly impacts the quality operations activities and batch release processes.

What kind of work environment can I expect?

You can expect a young, dynamic, and exciting work environment that focuses on innovation and collaboration within the pharmaceutical development space.

Will I be involved in client interactions?

Yes, you will participate in technical and managerial meetings with clients, as well as customer visits and audits by customers and regulatory authorities.

Is problem-solving a key skill for this role?

Yes, good problem-solving abilities are important, along with excellent communication, teamwork skills, and the ability to prioritize tasks under time constraints.

What are RFT and OTD in the context of this role?

RFT stands for "Right First Time," and OTD stands for "On-Time Delivery." These are quality indicators that the role will help to achieve through effective quality operations and documentation submission.

Is training provided for new employees in this position?

Yes, training will be conducted for personnel involved in Quality activities in the Pharmaceutical Development Service Unit.

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.