Proclinical is seeking a QA Validation Expert to ensure regulatory compliance and quality assurance for processes and equipment in a pharmaceutical setting. This role involves working closely with technical teams to review and approve validation protocols, ensuring the safety, efficiency, and reliability of pharmaceutical products.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
* Review validation protocols for equipment, processes, CIP, SIP, computerized systems, and HVAC/Utilities.
* Ensure compliance with GMP requirements and international regulatory guidelines.
* Evaluate validation results and confirm protocol requirements are met.
* Identify discrepancies and propose corrective actions.
* Collaborate with technical departments to integrate quality approaches.
* Participate in project meetings, providing expertise on validation-related quality aspects.
Key Skills and Requirements:
* Degree in a scientific field such as pharmacy, biotechnology, or chemistry.
* Experience in a similar role within the pharmaceutical industry under GMP conditions.
* Expertise in process, equipment, CIP, SIP, and computerized systems validation.
* Strong knowledge of GMP standards and international regulations.
* Familiarity with risk management methodologies and validation protocols.
* Analytical mindset with attention to detail.
* Excellent communication skills for collaboration with multidisciplinary teams.
* Solution-oriented with the ability to manage multiple projects under tight deadlines.
* Proficiency in English and French is an asset.
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