QA Specialist | Biopharmaceutical Manufacturing (NL/EN)

Vulcain Engineering Group | Belgium; Geel; Sur place; EUR 45 000 - 51 000; Plein temps

Avantages offerts par ce poste

Company car and fuel card

Meal vouchers

Insurance coverage

Eco cheques

Sectorial bonus

Résumé du poste

Vulcain Engineering Group | Belgium is seeking a QA Specialist to join a leading biopharmaceutical manufacturing environment. You will support Quality Assurance activities within a multiproduct Drug Substance facility, ensuring GMP compliance and data integrity across manufacturing operations.

You will review batch records, manage quality documentation, and collaborate with cross-functional teams to drive continuous improvement in quality processes and documentation management.

Qualifications

• Bachelor's or Master's degree in a scientific discipline or equivalent experience in a regulated setting is required.
• 2+ years of Quality Assurance experience in pharmaceutical, biotechnology, life sciences or other highly regulated environments.
• Strong knowledge of cGMP requirements, quality systems and Data Integrity principles.
• Experience with batch record review and GMP documentation management.
• Familiarity with deviations, CAPAs, change controls and document management is a plus.
• Team-oriented professional capable of working in a multidisciplinary environment.
• Fluent in Dutch and English.

Responsabilités

• Perform quality reviews of batch records and logbooks in electronic and paper formats.
• Manage issuance, control and archiving of batch records, logbooks and other quality documents.
• Review and approve operational documents requiring QA oversight, including SOPs, forms and work instructions.
• Own and maintain quality documentation, ensuring GMP compliance.
• Provide QA oversight and support related to alarm management activities.
• Ensure compliance with GMP regulations, quality procedures and data integrity requirements.
• Collaborate with Manufacturing, Engineering, Validation and other cross-functional teams to support operational excellence.
• Contribute to continuous improvement initiatives within Quality.

Connaissances

Quality Assurance

cGMP

Data Integrity

Batch Records

Deviations

CAPAs

Change Controls

Document Management

Team Collaboration

Dutch & English

Formation

Bachelor's or Master's degree in a scientific discipline

Description du poste

We are looking for a QA Specialist to join a leading biopharmaceutical manufacturing environment and support Quality Assurance activities within a multiproduct Drug Substance facility.

As part of the QA Operations team, you will play a key role in ensuring GMP compliance across manufacturing operations. Working closely with production teams, you will provide quality oversight, support documentation review activities, and help maintain the highest standards of quality and data integrity throughout the manufacturing process.

ABOUT THE POSITION:

• Perform quality reviews of batch records and logbooks in both electronic and paper-based formats.
• Manage the issuance, control, and archiving of batch records, logbooks, and other quality-critical operational documents.
• Review and approve operational documents requiring QA oversight, including SOPs, forms, and work instructions.
• Own and maintain quality documentation, ensuring compliance with GMP requirements.
• Provide quality oversight and support related to alarm management activities.
• Ensure compliance with GMP regulations, quality procedures, and data integrity requirements.
• Collaborate closely with Manufacturing, Engineering, Validation, and other cross-functional teams to support operational excellence.
• Contribute to continuous improvement initiatives within the Quality organization.

ABOUT YOU:

• Bachelor's or Master's degree in a scientific discipline, or equivalent experience within a regulated industry.
• 2+ years experience in Quality Assurance within pharmaceutical, biotechnology, life sciences, or other highly regulated environments.
• Strong knowledge of cGMP requirements, quality systems, and Data Integrity principles.
• Experience with batch record review and GMP documentation management.
• Familiarity with quality processes such as deviations, CAPAs, change controls, and document management is considered an asset.
• Team-oriented professional capable of working effectively in a multidisciplinary environment.
• Fluent in Dutch and English

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 slightly more than 120 consultants and synergies between the different business units