Documentation Reviewer I (1 year contract) hos Thermo Fisher Scientific

Udløber om 13 dage


Job ID :
88069BR
Location :
Canada - Whitby
:
Job Description

How will you make an impact?

With 70000 extraordinary minds on our global team, each one of us at Thermo Fisher has an important story to tell. Whether we’re helping customers to fight disease, making sure our air is clean, or solving cold cases, our stories involve thousands of important projects that improve millions of lives. Our dedicated sales professionals are laser focused on delivering our customer value proposition—accelerating innovation and enhancing productivity. With talented managers and inspiring coworkers to support you, you’ll find the resources and opportunities to make significant contributions to the world.

What will you do?

Reviews various technical reports and raw data generated in Pharmaceutical Development Services (PDS) – Analytical Development (AD). Verifies and confirms the integrity and traceability of all data generated and reported.

Essential Functions:

Reviews with minimum supervision all regular technical documents (e.g., batch testing, stability testing and method validation) and raw data generated in the PDS - AD with high quality and deliver within agreed schedule. Ensures the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the chemists. Verifies the integrity and traceability of all data generated and reported. Follows up with chemists to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices’ standard. Notifies department supervisor/manager regarding omissions, incomplete testing results or other irregularities. May be essential to perform alternating or rotating shift work (as required) Other duties as assigned

How will you get there?

Education and Experience:
  • B.Sc. in Chemistry
  • 1 year of previous pharmaceutical industry experience in an analytical development function.

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Basic understanding of common analytical technologies e.g. High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet (UV) spectroscopy, titration. Basic understanding of Good Manufacturing Practices, International Conference on Harmonization (ICH) and United States Food & Drug Administration (FDA) requirements. Knowledge of Good Manufacturing Practices (GMPs). Excellent communication skills (both oral and written), and organizational skills. Strong computer proficiency with Microsoft (MS) Office programs. Ability to meet deadlines and prioritize. Proficiency with the English Language.
Thermo Fisher Scientific is an equal opportunity employer and is committed to the principle of diversity and is particularly interested in receiving applications from a broad spectrum of people. Accommodations for job applicants with disabilities are available upon request.
Canada - Whitby
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