QA Validation Specialist

15/06/20

Location

Rue de Namur 73D Bruxelles Belgium

Function type

full-time

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 430 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 QA Validation Specialist to reinforce its Consulting team. As a consultant you will bring your expertise to our customer team. For this particular project, the main objectives are:

  • Ensuring quality for the validation part in the QIP autoclaves decontamination project

  • Perform an Oversight QA of validation activities

  • Actively participate in the design phases of the project in order to define change control strategies and validation (VP) in collaboration with project / validation teams

  • Review and approve all the documentation related to validation (IQ-OQ-PQ)

  • Establish a risk mitigation relating to the project before its implementation

  • Participate in the investigation of deviations and troubleshooting

  • Review and follow change control related to technical modifications

  • Monitor and approve CAPA related to projects

  • Carry out efficiency checks on the new methods implemented

  • Review the routine SOPs related to the modifications followed within the framework of the projects

  • Review and approve all documentation related to the projects for which it is responsible: TCD, QRA, CRA, protocols and IQOQ reports, PQ protocols and reports

  • Actively participate in the project and process design phase, to understand the project and to establish the proper implementation strategy (change control) and validation

  • Establish your load schedule according to the project schedule

  • Be responsible for the chronological and logical execution of commissioning, qualification, validation and decommissioning within the framework of projects; and this until the return to production of the project

  • Review routine SOPs related to the project

  • Write validation plans and validation summary reports

  • Review VM files related to the project

  • Review deviations / CAPA related to validations

  • Actively participate in project follow-up meetings, troubleshooting and various issues, in order to anticipate impacts or risks validations, and participate in the development of solutions

  • Ensure Oversight QA on the methods implemented

  • Provide coaching / transfer / handover of knowledge related to the project

 

START DATE: asap

WORK LOCATION: Walloon Brabant, Belgium

 

ABOUT YOU:

  • Master’s degree in Life sciences with at least 5 years’ experience in pharmaceutical industry required

  • Experience in an aseptic / laboratory environment, industry, quality, production

  • Experience in a regulated environment such as cGMP & in industry validation

  •  Knowledge of attenuated viral processes is a plus

  • Advanced knowledge of aseptic technologies, autoclaves, Utilities & Facilities

  • Qualification as QA Validation (VP, IOQ, PQ, VSR, WO)

  • Fluent communication and presentation skills in English and French


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.

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