Description
Our client is a multinational pharmaceutical company and is looking for a Validation Coordinator to ensure validation and technical coordination tasks related to several projects. The Validation Coordinator will work for our client in Belgium for at leaqst 6 months.
Scope of work:
* To coordinate for License, and CMO the adequate support (Validation, IQOQ, PQ, VMP, VSR, Qualification documents)
* Act as validation and technical coordinator for CMO and international project (providing all technical informations to the SPOC product transfer)
* These several supports will cover the following expertise, media preparation, primary process (upstream and downstream processes) secondary processes (formulation, filling, visual inspection, CCIT, Packaging, aseptic processes, ) transversal support (HVAC, environmental monitoring, CIP, SIP, clean utilities, Extractable & Leachable, bioburden, homogeneity, inactivation, filters, cartridges life time, ) and providing the risk assessment support
* Ensure the availability of the all documentation required to support the validation (URB, BD, FAT, SAT, IQ, OQ, VMP, PQ, VSR, Continuous Validation, risk assessment, .). from the donor sites or from the existing library
* Supporting the current team structure
Requirements:
* University degree in the Pharma and/or Biotechnology field
* Validation skills
* Scientific and technological know-how related to vaccine primary and secondary manufacturing operations.
* Expertise in Validation (V-cycle) and technical (Maintenance, C&M and requalification)
* Strong knowledge of aseptic operations
* Knowledge of international regulations (FDA, PIC's, WHO, Eudralex and local cGMP)
* Good communication skills.
* Customer focus
* Engaging, influence and transferring technical skills
* Adaptability to the international culture
* experience in Primary or secondary manufacturing of vaccines/Project Management/Validation (> 5 years)
Keywords: validation, IQ, OQ, PQ, qualification, commissioning, C&Q, validation, ingénieur validation, qualification, validation coordinator, GMP, validation