Job description
Job Offer: Validation Project Coordinator
Mission Description:
As a Validation Project Coordinator, you will be responsible for leading and coordinating validation activities for major GMP projects related to Drug Substance and Drug Product manufacturing. You will ensure that validation strategies are state-of-the-art, from the planning phase through to the Validation Summary Report. Your responsibilities will include drafting, reviewing, and approving validation documents such as Risk Assessments, IQ/OQ/PQ protocols, and reports, as well as coordinating the execution of validation protocols.
Key Responsibilities:
* Coordinate validation activities for major GMP projects in Drug Substance and Drug Product.
* Develop and implement validation strategies and plans.
* Draft, review, and approve validation documentation (Risk Assessments, IQ/OQ/PQ protocols, reports).
* Oversee and coordinate the execution of validation protocols.
* Ensure compliance with regulatory requirements and internal standards.
* Collaborate cross-functionally within a matrix organization.
Profile Requirements:
* Minimum 5 years of experience in validation within a GMP environment.
* Expertise in IQ/OQ/PQ validation and strong knowledge of GMP.
* Experience in project management and working within a matrix organization.
* Excellent communication, organizational, and influencing skills.
* Experience with injectable product validation.
* Fluent in French and English.
* Commitment to Diversity:
We are proud to be an equal opportunity employer. We are committed to promoting diversity within the workforce and creating an inclusive working environment. Therefore, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.