QA Review Specialist (Validation)

Vulcain Engineering - Belgium; Brussel Hoofdstad; Sur place; EUR 45 000 - 51 000; Plein temps

Avantages offerts par ce poste

Company car

Fuel card

Representation fees

Insurance packages

Meal vouchers

Eco cheques

Sectorial bonus

Résumé du poste

Vulcain Engineering is seeking a QA Validation Specialist to join its Quality Department in Belgium. The role ensures qualification and validation activities comply with GMP and regulatory expectations, reviewing IQ/OQ/PQ protocols and validation reports while supporting inspection readiness.

The candidate will collaborate with Validation, Engineering, Manufacturing and Project teams to maintain accurate, inspection-ready documentation and promote a quality culture across the lifecycle.

Qualifications

• Bachelor's or Master's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Engineering or related discipline.
• Minimum 2 years of experience in Quality Assurance, QA Validation, QA Review or GMP-regulated quality function.
• Experience performing QA review and approval of qualification and validation documentation.

Responsabilités

• Act as the Quality representative for qualification and validation activities.
• Review and approve validation documentation including IQ/OQ/PQ and validation reports.
• Ensure activities meet GMP requirements and regulatory expectations.
• Provide QA oversight and support to project teams.
• Participate in audits and respond to quality observations.

Connaissances

QA Validation

GMP Knowledge

Documentation Review

Cross-functional Collaboration

Formation

Bachelor's/Master's in Life Sciences/Engineering

Description du poste

As part of our Life Sciences activities, we are looking for a QA Validation Specialist to join the Quality Department of a leading pharmaceutical company. In this role, you will act as the Quality representative for qualification and validation activities, ensuring that projects comply with GMP requirements, quality standards and regulatory expectations throughout their lifecycle. Working closely with Validation, Engineering, Manufacturing and Quality stakeholders, you will provide QA oversight and review of validation deliverables while supporting inspection readiness and continuous compliance.

ABOUT THE POSITION:

• Act as the Quality representative for qualification and validation activities related to equipment, utilities, facilities and manufacturing processes.
• Perform QA review and approval of validation documentation, including Validation Plans, Risk Assessments, IQ, OQ, PQ protocols and validation reports.
• Ensure qualification and validation activities are conducted in accordance with GMP requirements, internal quality procedures and regulatory expectations.
• Review and approve deviations, CAPAs and change controls associated with validation activities.
• Provide quality guidance and support to Validation, Engineering, Manufacturing and Project teams.
• Ensure validation documentation remains accurate, complete and inspection-ready.
• Participate in internal and external audits and support responses to quality observations.
• Promote quality culture and continuous improvement within qualification and validation processes.
• Collaborate with cross-functional teams to ensure project deliverables meet both quality and business requirements.

ABOUT YOU:

• Bachelor's or Master's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Engineering or a related discipline.
• Minimum 2 years of experience in Quality Assurance, QA Validation, QA Review or a comparable GMP-regulated quality function.
• Experience performing QA review and approval of qualification and validation documentation.
• Knowledge of equipment, facilities, utilities and process qualification/validation activities.
• Good understanding of GMP requirements, quality systems, deviations, CAPAs and change control processes.
• Ability to work effectively with multidisciplinary teams and challenge documentation when required.
• Strong attention to detail, organizational skills and a quality-focused mindset.
• Fluency in English is mandatory, combined with either Dutch or French.

ABOUT VULCAIN:

Vulcain Engineering is a group specialized in the energy sector that supports companies active in Renewable & Nuclear Energy, Gas & Infrastructure through our Study Offices and Consultancy services. Vulcain Engineering Group is positioned as a transformation partner thanks to its ultra-specialization in strategic sectors which positively impact the transformation of our society and supports its clients in their transformation towards more sustainable and responsible models. Vulcain supports its clients throughout the entire life cycle of their projects, from design to commissioning, by integrating constructability and safety requirements right from the design phase.

In Belgium, our activities focus on consultancy services, delivering expertise in three main areas:

• Energy/Infrastructure
• Gas, Renewables & Processes
• Life Sciences

With headquarters based in Brussels, and clients spread all over the country, we address key projects in the Belgian industry, offering our consultants the opportunity to work on challenging topics and discover different areas during their time at Vulcain.

Why would you apply?

• An annual gross salary ranging from 45 000€ to 51 000€ paid over 13,92 months and advantages such as a company car (and fuel card), representation fees, insurances, meal vouchers, eco cheques, a sectorial bonus (the annual salary may vary according to your exact level of experience)
• A tailored career path within the company : opportunities to discover different business units, training, follow-up from your business manager, and a development evaluation every year
• A human-based company with more than 120 consultants and synergies between the different business units