Supervisor Documentation Review Job in Mississauga for Thermo Fisher Scientific | Jobs.ca
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Supervisor Documentation Review

May 13 2021
Industries Pharmaceutical, Biotechnology
Categories Archivist, Documentalist, Supervision, Surveillance, Trades, Technicians, Construction
Mississauga, ON

Job Title: Supervisor Documentation Review
Work Location: Mississauga, CA
Division: Pharma Services Group (PSG)


What Will You Do?

Ensures the data, protocols and reports consistently meet the requirements for current Good Manufacturing Practices, Good Laboratory Procedures (GLPs), Regulation and Thermo Fisher Scientific Standard Operating Procedures (SOPs) and policies. Assists the Group Leaders with schedules and supervises the activities of the Documentation Review and Report writing groups. Ensures the projects are completed on time. This position requires participation in all activities related to development of a “Best in Class” pharmaceutical laboratories organization.

Essential Functions:

  • Reviews analytical reports and other technical documents.
  • Provides technical leadership for analytical challenges and ensures the data generated in the Analytical Operations (AO) / Development Operations (DO) labs in accordance with testing procedures cited and is in compliance with SOP, Good Manufacturing Practices and GLPs.
  • Consult with Supervisors/Managers of the lab for required corrections, procedural deviations and approval.
  • Trouble shoots and answers Documentation Reviewer’s questions/solve problems.
  • Directly supervises and coaches staff in the performance of their duties while creating a team atmosphere.
  • Participates in the development of a “Best in Class” analytical development organization as it relates to people, technical excellence and business practices.
  • Communicates and coordinates with all Thermo Fisher Scientific sites and Project Manager’s to complete and revise reports, present and discuss report matters with other Thermo Fisher Scientific facilities
  • Provides insight to Manager on any general concerns or problems encountered by the data reviewing group.
  • Coaches AO/DO groups in good documentation practices and compliance of current quality standards.
  • Ensures all staff is meeting regulatory compliance, all SOPs are followed, and documentation is assessed against current ALCOA+ principles.
  • Selects, develops (goal setting) and evaluates staff to ensure the efficient operation of the function. Works with and advises staff on administrative policies and procedures.
  • Performs alternating or rotating shift work (as required)

How Will You Get Here?

Education:

Bachelor of Science (B.Sc.) in Chemistry or related science.


Experience:

Minimum 5 years’ experience in quality control/analytical development within the pharmaceutical industry.

Previous Supervision and/or leadership and training experience.


Equivalency:

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

Competencies:

Previous method and analytical instrumentation validation experience in the pharmaceutical industry. Excellent knowledge of Good Manufacturing Practices, Good Laboratory Practices (GLP), International Conference on Harmonization (ICH) and United States Food and Drug Administration (FDA) compliance knowledge. Ability to read, analyze, and interpret technical procedures and governmental regulations. Well organized and detail oriented. Strong interpersonal and communication skills (both oral and written). Ability to work well independently and in a team environment. Ability to meet deadlines and prioritize. Demonstrated computer proficiency with Microsoft Office programs. Proficiency in the English Language.