Risk assessment - investigation - French mandatory
We are seeking an experienced MS&T Lead Investigator to join our Manufacturing Development team. In this role, you will be accountable for conducting and leading deviation investigations to completion, ensuring timely, effective, and compliant outcomes. The scope of work spans across pharmaceutical manufacturing processes including bulk production, packaging, warehousing, technical services, and complaint handling.
Key Responsibilities
* Lead and manage deviation investigations from triage to conclusion
* Conduct root cause analysis and ensure effective corrective and preventive actions (CAPAs)
* Support initial risk and impact assessments in collaboration with Quality Operations
* Partner with Quality Assurance, Production, QC, Warehouse, and Engineering to ensure comprehensive investigations
* Prepare investigation reports and present findings at site and global levels
* Conduct complaint investigations and contribute to continuous improvement initiatives
* Share best practices and support projects within the MS&T function
* Provide support to other MS&T teams (e.g., robustness, qualification) as required
Candidate Profile
* Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related discipline (or equivalent experience)
* Minimum 5–8 years of experience in pharmaceutical operations, validation, quality assurance, packaging, or manufacturing support (ideally in Oral Solid Dosage environment)
* Strong GMP background and solid understanding of pharmaceutical facilities, manufacturing, and laboratory systems
* In-depth knowledge of regulatory requirements (cGxP, EU-GMP, 21 CFR part 11/210/211, Annex 11, GAMP)
* Proven technical writing abilities (e.g., investigation reports)
* Strong analytical, problem-solving, and organizational skills with the ability to work under tight deadlines
* Excellent communication and interpersonal skills, able to work effectively across functions and levels
* Fluency in English and French is mandatory
* Experience with Health Authority inspections (preparation, process, responses) is a plus
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