Freelancer profile translated to English.

Description

Versatile Consultant in Quality Assurance and Control (QA/QC), and Validation/Qualification in the Pharmaceutical Industry

With over 21 years of experience in the pharmaceutical sector, I am a highly qualified freelance consultant specializing in quality assurance (QA), quality control (QC), and the validation/qualification of equipment and processes.

My profile is distinguished by a rare and comprehensive understanding of the various links in the pharmaceutical value chain, acquired through working on key projects for major companies such as GSK, Takeda, and Baxter.

My areas of expertise include:

Quality Assurance (QA):

- Management and review of deviations, CAPA, and Change Control.

- Conducting audits and document reviews to ensure regulatory compliance.

- Management of supplier quality and risks related to raw materials.

- Validation of production areas at the environmental level.

- Validation of production and quality control equipment.

Quality Control (QC):

- Management and supervision of the proper functioning of chemistry and microbiology laboratories.

- Management of equipment and materials, and their compliance.

- Training and coaching of technical teams.

- Management of stability studies.

Validation and Qualification:

- Writing and approving validation documentation, including protocols and reports (IQ/OQ, PQ, QSR).

- Supporting validation activities for manufacturing equipment and processes.

- Implementing validation strategies compliant with FDA and EMEA standards.

Thanks to this transversal approach, I can bring specialized expertise to various missions, whether it involves managing a project to improve quality systems, validating new equipment, or leading a team.

I am available for missions in Belgium, in the south of Brussels and Walloon Brabant.

Do not hesitate to contact me to discuss your needs.

Industry field of expertise

Languages

French
Native or bilingual
English
Conversational
Dutch
Basic

Workplace preferences

Can work on-site

Nivelles (up to 30km)

MITHRA
VALIDATION ENGINEER, CONSULTANT
PHARMACEUTICALS INDUSTRY
January 2022 - December 2022 (11 months)
Flémalle-Haute, HT, Belgium
- To write and approve the validation documentation regarding the cGMP requirements (GAP analysis, VP, (pre) PQ, QSR)
- Responsible for the implementation of the validation policies for the processes and equipment activities
- To write and approve IQ/OQ and ensure coordination with all key players
- Responsible for defined expertise validation and for validation strategy harmonization
- Responsible for implementation of adequate validation strategies in compliance with FDA, EMEA and International quality standards
- Responsible for delivering validation services, for deviation root cause investigation and closure
L'ATELIER BARBAVAN Virginal-Samme,
VEHICLE CONVERTER, BUSINESS MANAGER
ARTS AND CRAFTS
January 2023 - Today (3 years and 5 months)
Ittre, Belgium
• Vehicle interior design:
│ Electrical system design and installation
│ Vehicle insulation
│ Window installation
│ Design and construction of wooden interiors for various type
│ 3D design using Fusion 360
│ Use of a CNC machine
│ Certified in furniture covering with thermoforming adhesive
CENEXI
QA SPECIALIST, CONSULTANT
PHARMACEUTICALS INDUSTRY
June 2021 - July 2021 (1 month)
Braine-l'Alleud, BW, Belgium
- To prepare protocol and Batch record for Japan Packaging.
- To update SOP's of release (MP, PF)
- To prepare SOP's of training