QA Batch Record Specialist (Pharma)

TL;DR

QA Batch Record Specialist (Pharma): Driving operational quality performance and material master data quality in a GMP-regulated environment with an accent on batch record review and master data governance. Focus on ensuring compliant product supply, managing non-conformances (CAPA), and acting as a quality spokesperson during regulatory audits.

Location: Onsite in Belgium

Company

Independent technology consulting firm providing guidance and solutions to businesses across 60 countries.

What you will do

• Perform QA batch record reviews and serve as the primary quality point of contact for the site.
• Manage material master data in SAP, approving setups for commercial and NPI products.
• Oversee quality issues, ensuring timely investigation of non-conformances, CAPAs, and change controls.
• Act as a quality spokesperson and Subject Matter Expert (SME) during regulatory inspections and audits.
• Drive continuous improvement initiatives to enhance organizational compliance and quality performance.
• Provide coaching and training on cGMP requirements to supporting departments.

Requirements

• At least 3 years of experience in the chemical or pharmaceutical industry.
• Thorough knowledge of cGMP regulations and guidelines.
• In-depth understanding of qualification, validation, manufacturing, packaging, and release processes.
• Ability to make risk-based decisions under time pressure and work independently.
• Strong communication, negotiation, and presentation skills.

Nice to have

• Experience as a release responsible or QP support.
• Proficiency with SAP material master data and related workflow tools.
• Experience with regulatory inspections and preparedness.

Culture & Benefits

• Opportunities for rapid professional growth within a fast-expanding Belgian workforce.
• Engagement in prestigious projects with renowned pharmaceutical and biotechnology clients.
• Dynamic, agile international environment promoting intrapreneurship and meritocracy.
• Commitment to diversity, equity, and an inclusive working environment.

Hiring process

• Brief virtual or phone call to align motivations and fit.
• Up to three interviews with line managers and team members.
• Potential case study or technical assessment depending on the role requirements.