QA RELEASE ENGINEER

20-6-2018 puurs
description de la société

For a major player in the global pharmaceutical industry, we are looking for a QA Release Engineer.

description de la fonction

Randstad’s mission is to shape the world of work by being a world leader in matching supply and demand in the labor market and in HR services.
Randstad Professionals is part of the Randstad Group and creates opportunities for highly qualified and skilled professionals to work on successive projects on customers’ site.

PRINCIPAL ACCOUNTABILITIES:

Assure that products manufactured and packaged in Puurs and by Third Party Manufacturers to the Puurs plant meet Company and legal requirements.
Assure that products purchased and used in the Puurs plant meet Company and legal requirements.
Investigate batches not meeting specifications and prepare recommendations to the QA Manager/QA lead.
Coordinate cross functional investigations in case of complex root causes and work closely with Manufacturing Operations and supporting departments.
Evaluate root cause analysis, corrective and preventive actions and verify effectiveness in order to prevent recurring deviations.
Evaluate incidents that occur in the facility of your area and prepare recommendations to the QA Manager/QA lead.
Operate and maintain the Quality Assurance systems.
Review batch related manufacturing documentation for conformity.
Approve master documents and SOP's.
Prepare Annual Product Reviews and Quality Performance Review.
Prepare necessary release documentation for your area.
Design the test plans for products in your area.
Support continuous improvement of products and processes through:
Quality deviation investigation (events/QAR's)
Trending of LIR, events and QARs
Participation in operations, product and system teams and Daily Operations Review meetings

Contribute to timely supply of products.
Release authority:
Product batches that meet Company and legal requirements (PQS, GMP etc).
Every Quality Assurance Report (QAR) needs to be approved by the Quality Assurance Lead, Manager QA, SQOL or Opu QL as described in the effective SOP.

vos atouts

EDUCATION, TRAINING AND/OR EXPERIENCE

Degree: University degree in a scientific discipline, preferably in Pharmacy
Specific training and skills required
Analytical skills
Good communication skills, verbal and in written, in Dutch & English
Excellent documentation skills (technical report writing in Dutch/English)
Good time management and prioritizations skills
Human interactions (diplomacy, convincing, assertiveness, ...)

Nice to have
Preferably experience in a manufacturing environment or packaging environment
Experience with quality investigations and release of biological products or vaccines

qu'offrons-nous?

You are flexible and you will receive a lot in return. You will get an attractive salary package with extra benefits:
- group insurance,
- hospitalization,
- meal vouchers,
- representation costs
- training, ...

sommaire
fonction
spécialiste en qualité et environnement (m/f)
type de job
temps plein, freelance
type contrat
missions à long terme
référence
CXRSP-68918
informations de contact
Anaïs Bosmans
Anais_Bosmans@professionals.randstad.be 02 472 68 38
02 472 68 38

informations de l'agence
HR Center Berchem
Posthofbrug 10
2600 BERCHEM (ANTWERPEN)
003232002848
003232002848