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QC PDS Reviewer

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

AI generated summary

  • You need a relevant degree, 2-3 years lab experience, GMP knowledge, analytical technique expertise, and strong communication skills. Adaptability and teamwork are essential.
  • You will review and evaluate analytical data, ensure compliance with SOPs and cGMP standards, maintain documentation, prepare scientific documents, and support laboratory safety programs.

Requirements

  • Bachelor’s degree in chemical pharmaceuticals, biology, chemistry, biotechnology, or a related field (Master’s degree preferred) or equivalent experience.
  • 2-3 years of laboratory experience, preferably in pharmaceuticals, biotechnology, healthcare, research, or academia.
  • Proficiency in Office programs and laboratory computer systems.
  • Knowledge of GMP standards and company procedures.
  • Expertise in analytical techniques and instrumentation (HPLC, FT-IR, UV-VIS, etc.).
  • Experience in Analytical Method Development/Transfer and Validation.
  • Familiarity with stability and routine tests for APIs and finished products.
  • Proficient in English.
  • Flexibility and adaptability.
  • Strong organizational and planning skills.
  • Effective listening and communication abilities.
  • Teamwork and collaboration skills.

Responsibilities

  • Perform tasks and activities directed by the PDS AD&GMP Reviewer Team Leader, in compliance with SOPs and safety regulations.
  • Review and evaluate analytical data from various equipment (HPLC, GC, IR, UV-Spectrophotometer, and others) for small and large molecule analysis to support product development (API, Drug Product) and stability testing.
  • Review analytical data for raw materials, in-process & finished products, formulations, and ensure compliance with SOPs and cGMP standards.
  • Conduct reviews for Analytical Method Development, Transfer, and Validation, as well as routine and stability analysis.
  • Maintain documentation following ALCOA principles and prepare raw data packages for clients.
  • Participate in preparing scientific documents (e.g., methods, protocols, reports, and SOPs).
  • Contribute to laboratory safety programs, maintain an orderly environment, and oversee documentation of experiments.
  • Verify and evaluate analytical documentation for data integrity, ensuring compliance with priorities and quality standards.

FAQs

What is the work schedule for the QC PDS Reviewer position?

The work schedule is flexible, with a total of 40 hours per week.

What kind of environment will I be working in?

You will be working in a laboratory setting as well as an office environment.

What qualifications are required for this position?

A Bachelor’s degree in chemical pharmaceuticals, biology, chemistry, biotechnology, or a related field is required, with a Master’s degree preferred. Equivalent experience is also acceptable.

What level of laboratory experience is preferred for this role?

2-3 years of laboratory experience, preferably in pharmaceuticals, biotechnology, healthcare, research, or academia, is preferred.

What analytical techniques should I be familiar with?

You should have expertise in analytical techniques and instrumentation such as HPLC, FT-IR, UV-VIS, and others.

Is knowledge of GMP standards important for this position?

Yes, knowledge of GMP standards and company procedures is crucial for the role.

Will I be involved in preparing scientific documents?

Yes, you will participate in preparing scientific documents, including methods, protocols, reports, and SOPs.

What skills are essential for success in this role?

Important skills include flexibility, strong organizational and planning abilities, effective listening and communication skills, and teamwork and collaboration capabilities.

Is proficiency in English required?

Yes, proficiency in English is required for this position.

What are the responsibilities associated with reviewing analytical data?

Responsibilities include reviewing and evaluating analytical data from various equipment for product development and stability testing, ensuring compliance with SOPs and cGMP standards, and verifying data integrity.

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.