Qualification/Validation Quality Specialist

CONSULTYS BENELUX is looking for a Qualification/Validation Quality Specialist to reinforce its Consulting team.

The main objectives of a Q/V Quality Specialist are:

• Ensuring quality for the validation part in the equipments (production/labo, automated tools)

• 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 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

• Establish your load schedule according to the project schedule

• Write validation plans and validation summary reports

• 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

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

START DATE: ASAP

WORK LOCATION: Wallonia, Belgium

ABOUT YOU:

• Master’s degree in Life sciences with at least 2 years of experience in the pharmaceutical industry required

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

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

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

• Fluent communication and presentation skills in English and French

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 520 employees – each of them known for their technical and scientific expertise. Through our regional subsidiaries in France, Belgium, Switzerland, Germany and Canada, we offer everyone geographical stability, without a mobility clause in the contracts.

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.