Description
For one of its clients (pharmaceutical industry) located in Walloon Brabant, Harvey Nash is currently looking for a
QA Validation Consultant
Scope of work:
As a member of the QA validation in the 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 validation procedures.
* To take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan (CVP),
* To define the validation strategies through the change control process (RPC),
* To write and implement some validation documentation (VP, VSR, Risk Assessment, Gap Analysis),
* To review and approve specific qualiftion and validation documentation (IQ, OQ, PQ, PV),
* To ensure the correct application of the validation quality systems on the field and to define improvement plan as required,
* To support the production & technical services teams in the implementation of the validation activities,
* To ensure the adequate management of validation deviation (be QA GMP Responsible) and potentials CAPA (be Compliance Authority).
Requirements:
* 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
* Knowledge of GMP regulated environment
* Knowledge of filling process
* Capable of working as part of a multidisciplined team as well as an individual
* Good organizational skills and ability to manage their time and identify priorities
* An analytical, logical and practical person
* Good reactivity when facing challenges such as changes in schedule.
* Rigorous in following documentation
* A working knowledge of written and oral French and English.
Tags: QA, quality assurance
Harvey Nash is a tusted partner of Belgian pharmaceutical companies