QA Validation Engineer - Life Sciences (Flanders)

ALTEN; Vlaanderen; Sur place; EUR 55 000 - 85 000; Plein temps

Avantages offerts par ce poste

A permanent contract

Company car

Meal vouchers

Résumé du poste

ALTEN Belgium is seeking a QA Validation Engineer to support the QA Engineering department across the complete lifecycle of qualification/validation projects. You will help ensure regulatory and procedural requirements are fulfilled for manufacturing, laboratory, building, utility, IT, and automation systems.

The role requires experience in chemical or pharmaceutical industries, strong knowledge of cGMP, and the ability to translate technical information for diverse audiences.

Qualifications

• Experience in chemical or pharmaceutical industries with qualification/validation.
• Knowledge of cGMP regulations and guidelines.
• Ability to translate technical information for all levels of the organization.
• Ability to estimate urgency, criticality and impact of decisions.
• Ability to multitask and work on multiple projects.

Responsabilités

• Review and approve qualification/validation documents and quality records (SOPs, URs, Impact/Risk analyses, test plans/scripts, change controls, CAPAs).
• Collaborate with engineering teams and other groups for new or upgraded systems and processes.
• Provide advice and support for qualification/validation activities and cGMP compliance.
• Address and follow up on deviations during qualification/validation activities.
• Communicate status to QA qualification/validation team members.

Connaissances

Quality assurance

Regulatory compliance

Cross-functional teamwork

Technical writing

Analytical thinking

English and Dutch fluency

Outils

TrackWise

Comet

TruVault

Kneat

Description du poste

ALTEN Belgium is a leading consultancy company in the fields of Engineering, Life Sciences and IT in which our people and clients are central.

In our open and adaptable organization, we get the best out of our ambitious employees enabling them to perform optimally. We do this by offering them the most challenging projects, but also to continuously acquire new expertise to boost their careers. This can be done with the help of our ALTEN Academy, but also through our knowledge sharing events.

All employees together form a large network of expertise, even at an international level. In this way we offer optimal growth to our consultants and the best solutions for our customers.

Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too?

We are currently looking for a QA Validation Engineer to join our team.

As a QA Validation Engineer, you'll support the QA Engineering department in assuring that all Qualification/Validation-related regulatory and procedural requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase).

Multiple profiles are required and, based on the provided profile, a match will be made with one or more of the following specific sub-topics:

• Manufacturing Systems Qualification
• Laboratory Systems Qualification
• Facility and Utility Systems Qualification
• IT / Automation Systems
• Computer System Validation

Main responsibilities:

Review and approve qualification/validation documents and quality records such as: SOPs, User Requirements, Impact / Risk Analyses, Test Plans, Test Scripts, Change Controls, CAPAs, Maintain compliance with regulations, guidelines, and the company's policies and standards.

• Be part of engineering teams and interact with other groups for the introduction of new or upgraded systems and processes.
• Provide advice and support for the preparation of qualification/validation-related activities and safeguard cGMP aspects.
• Address and follow up on deviations occurring during the execution of qualification/validation activities.
• Communicate status (quality & compliance, planning, etc.) to QA qualification/validation team members.

Your profile:

Knowledge & Experience:

• Experience in the chemical and/or pharmaceutical industry with respect to qualification/validation.
• Knowledge of cGMP regulations and guidelines.
• Ability to translate technical information into content understandable at all levels of the organization.
• Ability to correctly estimate urgency, criticality, and impact of decisions related to the function.
• Ability to multi-task and work on a variety of projects simultaneously.
• Ability to work independently and in a cross-functional team environment.

Languages:

• Fluent in English and Dutch (written and spoken).

Specific Know-How:

• Systems: Manufacturing, Laboratory, Building, Utility, IT, Automation systems used within the pharmaceutical or chemical industry
• Problem reporting and change request systems (e.g. TrackWise, Comet)
• Document Management Systems (e.g. TruVault)
• Test tools (e.g. Kneat)

What ALTEN has to offer

• A permanent contract
• A salary package in line with your experience and extra benefits (company car, meal vouchers, recovery days, insurances)
• The possibility to join a great team and be part of the success story of an international group

We are also open to work with freelancers!