Description
For one of our clients in the pharmaceutical industry, we are currently looking for a "Validation coordinator C & Q"
START OF THE MISSION: ASAP
LENGTH: 6 months + possible extension
LOCATION: South of Brussels
FUNCTION DESCRIPTION:
Provide support to the project team for validation coordination(IQ/OQ/PQ/PV).
KEY RESPONSIBILITIES:
*Follow and coordinate the qualifications during a project
*Review and ensure the compliance of the qualification protocols, review the qualification raw data and finally approve the qualification reports for conformance
*Must be able to advice the different actors in case of issues ordeviations
*Has an expertise in all qualification aspects of vaccine manufacturing such as qualifications of HVAC systems, Clean Utilities (Clean Compressed Air, Clean Steam, Purified Water, Water For Injection, ...), autoclaves, analytical systems, CIP/SIP process, filling lines, bulk equipments (chromatography systems, fermentor, ) and a lot of other equipment commonly used vaccine manufacturing facilities and able tomanage most of these qualification aspects.
*Ensure that all GMP aspects are respected during the project.
*Able to manage the project respecting the established qualification timelines and coordinate all actors (Contractors, Engineering, Users) to align them with the qualification planning.
Education
*Have a scientific degree (Chemistry, Biochemistry, ...) or equivalent
Knowledge
*Bilingual French/English (written and spoken)
*cGMP
*Good experience in managing qualifications projects
*Good understanding of the injectable manufacturing processes
*Knowledge in qualifications of HVAC systems, Clean Utilities (Clean Compressed Air, Clean Steam, Purified Water, Water For Injection, ...), autoclaves, analytical systems, CIP/SIP process, filling lines, bulk equipments (chromatography systems, fermentor, )
Experience
*Have already demonstrated success in validation coordination in projects
*Over 5 years experience in validation in pharmaceutical area
*Good communication skills
*Ability to work under heavy pressure due to the requested flexibilityand reactivity of the activities
*Autonomous
*Ability to work in project teams in a multidisciplinary environment and a matricial organization