Validation Engineer – Pharmaceutical Sector

CDIC

Avenue Jules Bordet 168 1140 Bruxelles

01/25/2023

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Reference number

2023-26133

Category

Operations — Engineering/production

Business industry

Life sciences

Minimum level of education required

Bachelor Degree

Diploma specialization

Quality & Risk Management
Project Management
Pharmaceutics
Health, Safety and Environment
Chemistry / Biochemistry / Petrochemistry

Minimum level of experience required

1 to 3 years

Contractual hours

Full time

Location

Wallonia, Belgium

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Job description

AKKODIS Belgium is looking for an experienced person in a pharmaceutical environment in the field of validation.

Your responsibilities :

- Ensure the execution or review of the required pre-tests before starting the final implementation of new processes.

- Coordinate all GMP documentation required for change control management (VP - TCD - VSR - QAGMP authorisation - QAGMP approval - external quota documentation, etc.).

- Write or revise PQ validation protocols and reports and analyse the results during PQ runs.

- Ensure the planning of validations in partnership with the C&M/QA departments and production - Ensure communication with the production team in order to have the raw materials/assemblies/ad hoc resources for the validation.

- Ensure the operational management of the technicians dedicated to validations.

- Ensure all deviations related to the implementation of the change.

- Ensure the follow-up of QC results for each validation cycle. - Ensure timely collection/transfer of approved local documents to the RA department to ensure timely submission.

- Ensure review of dossier preparation in partnership with QA prior to submission of dossier to authorities.

 

Profile

Your profile:

- You have a master's degree in industrial biology/chemistry or an industrial pharmacist title.

- You have experience in project coordination in a pharmaceutical environment. A previous technical background is a plus.

- You have experience and technical skills in the pharmaceutical industry.

- You are fluent in French and English.

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