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QA Validation Specialist
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Engineering, Support, Engineer
Projektbeschreibung
Our client, a multinational company in the pharmaceutical industry requires QA Validation specialist.
MISSION SUMMARY:
As a member of the QA validation filling activities, the selected candidate will be responsible for:
The execution & follow-up of the IQ-OQ, PQ, validation periodic review, deviation and capa linked to the validation in accordance with GSK validation procedures.
ESSENTIAL FUNCTIONS:
The position includes responsibility for all or part of the following steps:
* Take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan (CVP),
* Define the validation strategies through the change control process (RPC),
* Write and implement some validation documentation (VP, VSR, Risk Assessment, Gap Analysis),
* review and approve specific qualification and validation documentation (IQ, OQ, PQ, PV),
* Ensure the correct application of the validation quality systems onthe field and to define improvement plan as required,
* Support the production & technical services teams in the implementation of the validation activities,
* Ensure the adequate management of validation deviation (be QA GMP Responsible) and potentials CAPA (be Compliance Authority).
PROFILE:
* Scientific university degree (Pharmacist, Engineer or equivalent)
* Minimum of 5 years experience in the pharmaceutical industry, engineering contractors
* Minimum of 3 years experience in validation
* Previous experience in the role of validation system
* Knowledge of GMP regulated environment
* Knowledge of filling process
* Capable of working as part of a multidisciplined team as well as anindividual
* Good organizational skills and ability to manage their time andidentify priorities
* An analytical, logical and practical person
* Good reactivity when facing challenges such as changes in schedule.
* Rigorous in following documentation and the project stages inaccordance to GSK requirements
* A working knowledge of written and oral French and English.
MISSION SUMMARY:
As a member of the QA validation filling activities, the selected candidate will be responsible for:
The execution & follow-up of the IQ-OQ, PQ, validation periodic review, deviation and capa linked to the validation in accordance with GSK validation procedures.
ESSENTIAL FUNCTIONS:
The position includes responsibility for all or part of the following steps:
* Take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan (CVP),
* Define the validation strategies through the change control process (RPC),
* Write and implement some validation documentation (VP, VSR, Risk Assessment, Gap Analysis),
* review and approve specific qualification and validation documentation (IQ, OQ, PQ, PV),
* Ensure the correct application of the validation quality systems onthe field and to define improvement plan as required,
* Support the production & technical services teams in the implementation of the validation activities,
* Ensure the adequate management of validation deviation (be QA GMP Responsible) and potentials CAPA (be Compliance Authority).
PROFILE:
* Scientific university degree (Pharmacist, Engineer or equivalent)
* Minimum of 5 years experience in the pharmaceutical industry, engineering contractors
* Minimum of 3 years experience in validation
* Previous experience in the role of validation system
* Knowledge of GMP regulated environment
* Knowledge of filling process
* Capable of working as part of a multidisciplined team as well as anindividual
* Good organizational skills and ability to manage their time andidentify priorities
* An analytical, logical and practical person
* Good reactivity when facing challenges such as changes in schedule.
* Rigorous in following documentation and the project stages inaccordance to GSK requirements
* A working knowledge of written and oral French and English.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges