Lead Investigator

4 weeks ago


Québec, Canada Kelly Science, Engineering, Technology & Telecom Full time

We are currently looking for a Lead Investigator (QA) for our pharmaceutical client based out of Baie-D'Urfé (Montreal), Quebec.

Contract duration: 9months
Hours: Standard, NO overtime (37.5 -40 hours in a week)
Location: Baie d'Urfe (onsite)- after 3months in the role, 2days remote in a week

Role summary:
This is a lead investigator role requiring strong understanding of GMP, investigation mindset, technical writing skills. Reporting deviations, analysis Fishbone diagram, 5Ms, etc. Working with regulatory agencies, writing down investigations, CAPA identification etc.

• Implement Quality Assurance plans and programs to develop methods to evaluate and improve the quality of products, materials, components and/or operations meet business needs
• Tracks the alignment of the Quality Assurance activities and reconcile any deviation from plans and processes
• Implement and execute Quality Assurance processes and policies through ongoing Quality Assurance support and solutions
• Implement, execute and maintain the programs and policies of Quality Assurance
• Contributes to the development and administration of all processes related to Quality Assurance programs and policies
• Collaborate with other activities of Quality Assurance like the quality of products and processes, including standard procedures (e.g., ISO 9001:2000, ISO 14000 family of standards), quality audits/review, Taguchi methods, process reengineering, etc.
• Participate in driving transformation and change of Quality Assurance practices

Experience Level:
Prefer 3 years of experience in technical writing.
Overall 5-8 years experience in Quality Assurance in pharmaceutical manufacturing is desirable.

Education Level:
Bachelor’s Degree in relevant stream or equivalent experience/qualification

Language:
English (Report writing is in English)
Functional French (to be able to connect verbally with French speaking stakeholders)- Intermediate and above is good.



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