Description
Harvey Nash is currently looking for a validation coordination bulk forone of its customer.
FUNCTIONDESCRIPTION
The mission is focused on the starting-up of the validation of theproduction activities in a brand new building in the NPI department.The building is dedicated to run clinical lots and new productsintroduction of our customer vaccine portfolio.The candidate will jointhe project team of a new Primary Building dedicated to GMP activities.The candidate will be the link between the project activities and themanufacturing activities.
KEYRESPONSIBILITIES
1. Phase 1: Represent the User in the followingresponsabilities:
o Initiate and define the PQ strategy to Qualify thefull building (PQMP and VP)
o Write PQ protocols.
o Write SOP releated to validation
o Execute IQ, OQ and PQ field activities.
o Organization of the follow-up of Change Controls(prioritization and follow-up of the progress).
o Supervizing deviations (leading the investigationand follow-up of the progress).
2. Phase 2: Represent the local Validation
o Review and approve IQ, OQ and PQ protocols
o Coordinate validation activities in the building
3. Act with a "User representative & Quality"responsibility and mindset.
PREREQUISITES
Education
* Have an engineering degree (chemistry, pharma,biotechnology, processes)
Knowledge
* Bilingual French/English
* Good communication skills
* Ability to work under heavy pressure due to therequested flexibility and reactivity of the activities
* Autonomous and achievements oriented
* Ability to work in project teams in amultidisciplinary environment and a matricial organization
* Would Harvey Nash is currently looking for avalidation coordination bulk for one of its customer.
FUNCTION DESCRIPTION
The mission is focused on the starting-up of the validation of theproduction activities in a brand new building in the NPI department.The building is dedicated to run clinical lots and new productsintroduction of our customer vaccine portfolio.The candidate will jointhe project team of a new Primary Building dedicated to GMP activities.The candidate will be the link between the project activities and themanufacturing activities.
KEY RESPONSIBILITIES
1. Phase 1: Represent the User in the followingresponsabilities:
o Initiate and define the PQ strategy to Qualify thefull building (PQMP and VP)
o Write PQ protocols.
o Write SOP releated to validation
o Execute IQ, OQ and PQ field activities.
o Organization of the follow-up of Change Controls(prioritization and follow-up of the progress).
o Supervizing deviations (leading the investigationand follow-up of the progress).
2. Phase 2: Represent the local Validation
o Review and approve IQ, OQ and PQ protocols
o Coordinate validation activities in the building
3. Act with a "User representative & Quality"responsibility and mindset.
PREREQUISITES
Education
* Have an engineering degree (chemistry, pharma,biotechnology, processes)
Knowledge
* Bilingual French/English
* Good communication skills
* Ability to work under heavy pressure due to therequested flexibility and reactivity of the activities
* Autonomous and achievements oriented
* Ability to work in project teams in amultidisciplinary environment and a matricial organization
* Would be a plus: methodological knowledge (Lean 6Sigma)
* cGMP and validation V cycle
Experience
* Minimum 5 years experience in validation
* Must be able to propose and define validationstrategy
* Mandatory previous experience in process equipmentssuch as fermentators, UF and chromato, sterilization and cleaning ofthese equipment. And environmental principel.
* Previous experience in one or more of the followingvalidation areas is a plus: Autoclave, washing machine and mobile tank.
* Would be a plus: experience in other validationareas, Pharma production or engineering experience.
be a plus: methodological knowledge (Lean 6 Sigma)
* cGMP and validation V cycle
Experience
* Minimum 5 years experience in validation
* Must be able to propose and define validationstrategy
* Mandatory previous experience in process equipmentssuch as fermentators, UF and chromato, sterilization and cleaning ofthese equipment. And environmental principel.
* Previous experience in one or more of the followingvalidation areas is a plus: Autoclave, washing machine and mobile tank.
* Would be a plus: experience in other validationareas, Pharma production or engineering experience.