Overview
Direct message the job poster from EPM Scientific.
We are looking for an experienced CQV consultant to support qualification and validation activities in a pharmaceutical environment. This is a temporary position for a duration of 6 months. The role involves managing equipment qualification projects and, ideally, computerized system validation (CSV). Experience in chemical production is highly desirable.
Main Responsibilities
* Commissioning & Qualification:
o Drafting and reviewing IQ/OQ/PQ protocols.
o Performing qualification tests on production equipment.
o Managing deviations and implementing CAPAs.
o Preparing and following up on qualification reports.
* Validation:
o Computerized System Validation (CSV) according to GAMP 5.
o Drafting URS, FS, DS, and test protocols.
o Ensuring compliance with regulatory requirements (FDA, EMA).
* Documentation & Compliance:
o Guaranteeing traceability and document compliance.
o Adhering to GMP standards and internal guidelines.
* Coordination:
o Collaborating with production, quality, and engineering teams.
o Participating in project meetings and providing regular reporting.
Profile
* Experience: Minimum 5 years in CQV roles with full mastery of associated activities (IQ/OQ/PQ qualification, protocol drafting, deviation management, CSV validation).
* Technical Skills:
o Qualification of pharmaceutical production equipment.
o Knowledge of computerized systems and CSV validation (a plus).
o Ideally, experience in chemical production.
* Languages: Fluent in French and English (spoken and written).
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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