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For an important international pharmaceutical industry based in Neuchâtel area, we are seeking a highly skilled :
Scientist Lead Investigator MS&T 100% H/F
French / English
to drive deviation investigations across all manufacturing operations, including bulk production, packaging, warehousing, and technical services. The successful candidate will ensure thorough root cause analysis, timely corrective and preventive actions, and compliance with global regulatory standards.
Scientist Lead Investigator MS&T 100% H/F
French / English
to drive deviation investigations across all manufacturing operations, including bulk production, packaging, warehousing, and technical services. The successful candidate will ensure thorough root cause analysis, timely corrective and preventive actions, and compliance with global regulatory standards.
Description du poste
• Lead and conclude investigations for manufacturing deviations, ensuring effective root cause analysis and CAPA implementation.
• Support triage and initial risk assessment of deviations in collaboration with Quality Operations.
• Partner with QA and operational teams (production, QC, warehouse, maintenance) to ensure comprehensive investigations.
• Provide clear reporting and communication at both site and global levels, including Investigation Review Boards.
• Conduct complaint investigations and share best practices across sites.
• Contribute to continuous improvement initiatives and support related MS&T projects.
• Execute additional tasks as assigned to support MS&T and operational excellence.
Profil attendu
• BS/MS in Engineering, Life Sciences, or related technical discipline, or equivalent experience.
• 5–8 years' experience in pharmaceutical operations, QA, validation, packaging, or related areas (Oral Solid Dosage experience preferred).
• Strong knowledge of pharmaceutical manufacturing, laboratory systems, and cGxP regulations (EU-GMP, 21 CFR 210/211/Part 11, Annex 11, GAMP).
• Experience with Health Authority inspections is a plus.
• Excellent analytical, problem-solving, and project management skills.
• Strong technical writing and communication skills; ability to work across functions and levels.
• Ability to manage multiple priorities under tight deadlines.
• Fluent in English and French.
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