Life Sciences Qualification & Validation Specialist

SmartRecruiters, Inc.; Brussel; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

ALTEN is seeking a Qualification and Validation Consultant to support projects in pharmaceutical production. You will coordinate and execute the validation cycle to meet timelines across Production, QA and Maintenance functions.

The candidate should have a degree in engineering with GMP validation experience and be fluent in English and French, with curiosity for process equipment and GMP documentation. This Belgian role offers diverse international project exposure.

Qualifikationen

• Experience in qualification and validation within a GMP environment.
• Knowledge of production processes in the pharmaceutical industry.
• Ability to work in English and French.
• Curious to learn about production equipment and manufacturing processes.
• Organized and meticulous in drafting GMP documentation.
• Communicative and able to interact with Production, Quality Assurance, Maintenance.

Aufgaben

• Represent the Validation department on various projects.
• Design and implement the best Validation strategy.
• Coordinate project planning with Production / QA / Maintenance.
• Participate in risk assessment through drafting a Risk Assessment.
• Draft Functional Specifications (FS) and Design Specifications (DS).
• Write protocols and coordinate tests (URS / FAT / SAT / IQ / OQ / PQ).
• Analyze results and draft reports.
• Develop training and coach operators; manage deviations and CAPAs.

Kenntnisse

GMP validation experience

Cross-functional collaboration

Documentation drafting

Ausbildung

Engineering degree

Master7s in Bioengineering

Industrial Pharmacy

Related fields

Jobbeschreibung

ALTEN is seeking a Qualification and Validation Consultant to support projects in pharmaceutical production. You will coordinate and execute the validation cycle to meet timelines across Production, QA and Maintenance functions.

The candidate should have a degree in engineering with GMP validation experience and be fluent in English and French, with curiosity for process equipment and GMP documentation. This Belgian role offers diverse international project exposure.