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Job Location | Mississauga, ON |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Full Time |
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues 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 and Patheon. For more information, please visit www.thermofisher.com.How will you make an impactYou will supervise the activities of the Lab Services Metrology Group. You will ensure that calibration and qualification activities for all new and existing analytical equipment are performed according to a set schedule and current Patheon Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), and corporate quality standards.What will you doEssential Functions:Directly supervises, coaches, and develops staff in the performance of their duties while creating a team atmosphere.Supervises Installation Qualification (IQ), Operation Qualifications (OQ), Performance Qualifications (PQ)and Preventative Maintenance (PM) activities on all new and existing equipment.Develops and maintains a calibration schedule for each new and existing piece of analytical equipment.Maintains detailed and accurate records to meet all regulatory and user requirements.Complies with all current SOPs and procedures.Designs SOPs/protocols for new pieces of lab equipment and update/review SOPs/protocols.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.Troubleshoots and repairs malfunctioning apparatus.Responds to emergency after-hours cellphone (as required).How will you get hereEducation:B.Sc. in science related to Pharmaceutical Analysis or analytical instrumentation.Experience:Minimum 5 years of instrumentation validation experience in the pharmaceutical industry.Previous Supervision and/or leadership and training experience.Equivalency:Equivalent combinations of education, training, and relevant work experience may be considered.Knowledge, Skills and Abilities: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.Well organized and detail oriented.Excellent problem-solving skills and logical approach to solving scientific problems.Strong interpersonal and communication skills (both oral and written).Ability to work well independently and in a team environment.Demonstrated computer proficiency with Microsoft Office programs.Proficiency with the English language.At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.