QA Validation Consultant

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