Pharma Computer System Validation Specialist

Consultys Benelux

www.consultys.be

contact@consultys.be

+32 473 52 37 52

Pharma Computer System Validation Specialist

14/09/20

Location

rue de Namur 73D Bruxelles Belgium

Vacancy

ABOUT US:

For nearly 15 years, the largest laboratories in the world have been showing their confidence in our company. Specialized in pharma, biotech and medical devices, we support our customers from research to product launch.

 We cultivate a human-scale company spirit that allows us to personally follow our 450 employees – each of them known for their technical and scientific expertise. Through our regional subsidiaries in France, Belgium and Switzerland, we offer everyone geographical stability, without a mobility clause in the contracts. 

JOB DESCRIPTION:

CONSULTYS BENELUX is looking for a Computer System Validation (CSV) QA specialist with at least 1 year of experience in CSV role in the Pharma sector.

As a consultant (employee or freelancer) you will bring your expertise to our customer team.

The main duties of the role is to ensure the proper execution of the qualification and validation activities with respect of the client validation methodology:

  • Writing, reviewing and approving of validation plans and validation summary reports

  • Reviewing and approving of Technical Change Description

  • Reviewing and approving of IQOQ protocols & reports, PQ protocols & reports, …

  • Reviewing of CSV specific SOP’s and Templates

START DATE: asap

WORK LOCATION: Walloon Brabant, Belgium

 ABOUT YOU: Required Experience & Knowledge:

  • Minimum 1 years’ experience in a computer systems validation role in the Biopharma sector

  • CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)

  • Validation practices and guidelines (life cycle approach, ICH, ASTM E2500, …)

  • Autonomy

  • Critical mind

  • Team player

  • Fluent in French & English

Do you want to integrate the consulting world into a human-sized company that values the individual and the performance? Do you want to invest in long-term innovative projects? To share your skills in a close-knit team where experiences are shared freely? So, join us! We offer you an attractive salary and fringe benefits. You will work in a stimulating international environment, with numerous opportunities for personal development.

Job application