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Quality Assurance Batch Records
Eingestellt von Harvey Nash Group
Gesuchte Skills: Consultant
Projektbeschreibung
QA expert for batch record review department (operator/technician level).
The company have to construct and install a new clean area (600sq m)- linked to that is HVAC, construction, installation. New equipment has to be purchased, installed and validation is needed linked to the equipment purchases in the new start up area. The QA dept is also increasing in size and in growing/expanding and this is all linked to the equipment coming in, so increase in workload and also production - so a lot of work
Role:
Purchase Equipment - make sure equipment validated - integrators, fridges, freezers, electricity (not production lines as they are in bio-safety cabinets) and IQ,OQ,PC/HVAC to walls, floors and their EMS system - all IQ/PQ equipment and installations to be validated
Person will be expected to produce validation documents and be part of the performance of validation processes
And on the QA side they will have to approve all validation documents/produce protocols and review & write protocols that are in French.
QA consultant
o Approval Specifications (materials and equipment) - IQ/OQ/PQ
o Approval of Master Batch Record
o In operation of a new warehouse (Appro. In procedures, IQ/OQ.PQ)
o New wing ( Appro SOP/Equipment/IQ/OQ/PQ)
o 5 to 10 years of experience in valid/qualif
o Exp. By launching new areas is a real plus
French & English is a must
Timelines - 9 month - 1 year contract
Start date - Monday 24th May (2 weeks most they can wait)
Location - Brussels, Belgium
Must haves - French and English, FRENCH is the work environment - essential as they will have to produce protocols and review protocols that are in French
Culture - very dynamic environment - work hard but people are smiling - good company to work for - seniority could be welcomed to improve working processes/habits but they don't want someone who comes in & is fixed on their ideas or processes as they don't have time for these changes or that inflexibility!
Please call Grace Mc Dwyer for more information on this role or email me at (see below)
The company have to construct and install a new clean area (600sq m)- linked to that is HVAC, construction, installation. New equipment has to be purchased, installed and validation is needed linked to the equipment purchases in the new start up area. The QA dept is also increasing in size and in growing/expanding and this is all linked to the equipment coming in, so increase in workload and also production - so a lot of work
Role:
Purchase Equipment - make sure equipment validated - integrators, fridges, freezers, electricity (not production lines as they are in bio-safety cabinets) and IQ,OQ,PC/HVAC to walls, floors and their EMS system - all IQ/PQ equipment and installations to be validated
Person will be expected to produce validation documents and be part of the performance of validation processes
And on the QA side they will have to approve all validation documents/produce protocols and review & write protocols that are in French.
QA consultant
o Approval Specifications (materials and equipment) - IQ/OQ/PQ
o Approval of Master Batch Record
o In operation of a new warehouse (Appro. In procedures, IQ/OQ.PQ)
o New wing ( Appro SOP/Equipment/IQ/OQ/PQ)
o 5 to 10 years of experience in valid/qualif
o Exp. By launching new areas is a real plus
French & English is a must
Timelines - 9 month - 1 year contract
Start date - Monday 24th May (2 weeks most they can wait)
Location - Brussels, Belgium
Must haves - French and English, FRENCH is the work environment - essential as they will have to produce protocols and review protocols that are in French
Culture - very dynamic environment - work hard but people are smiling - good company to work for - seniority could be welcomed to improve working processes/habits but they don't want someone who comes in & is fixed on their ideas or processes as they don't have time for these changes or that inflexibility!
Please call Grace Mc Dwyer for more information on this role or email me at (see below)
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Organisation/Management