Senior QA & QMS Lead: GMP & Batch Release

Prothya Biosolutions Belgium BV; Netherlands; Remote; EUR 52,000 - 75,000; Full time

Benefits offered by this job

30 holiday days

Training budget €2,100 every 3 years

Travel expense reimbursement

Pension plan

Public transport access

Job summary

Prothya Biosolutions Belgium BV is seeking a Senior QA Officer QMS to reinforce our Quality Assurance team. You will ensure GMP compliance, support QP batch release activities, and uphold high-quality standards across manufacturing operations, working with Manufacturing, Quality Control, Engineering, and Regulatory Affairs.

Key responsibilities include GMP and batch release, QA documentation, deviations and CAPA handling, internal audits and inspections, training, and continuous improvement to

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field.
• Experience in GMP-regulated pharmaceutical or biotechnology environment.
• Experience in QA Operations, Batch Release, or Quality Systems preferred.
• Knowledge of EU GMP guidelines.
• Strong analytical and problem-solving skills.
• Experience with deviation management and CAPA processes.
• Strong communication and stakeholder management skills.
• Detail-oriented with strong documentation skills.
• Ability to work independently and within cross-functional teams.

Responsibilities

• GMP & Batch Release Activities
• Preparation of QP batch release documentation for intermediates, Drug Substances, Drug Products, and Finished Products
• Batch record review and approval
• Physical release of products in the warehouse
• Ensure overall QMS compliance related to QA operational tasks
• Supervise QA Officers or junior personnel where applicable
• Communicate with OMCL where required
• Act as SME during internal audits and customer inspections
• Support regulatory audits and inspection readiness
• Present processes during audits where required
• Provide on-the-job training to QA Operations staff
• Support training in deviations, CAPA, and quality systems
• Write and review GMP procedures
• Review and approve GMP documentation (e.g., SOPs, Master Batch Records)
• Deliver quality data for monthly metrics and Quality Management Review
• Support Product Quality Review documentation
• Perform routine shopfloor QA oversight visits
• Coach junior team members
• Act as project lead where applicable (SME)
• Support Quality Lead in stakeholder management

Skills

Analytical thinking

Problem solving

Communication

GMP knowledge

QA Operations

Education

Bachelor’s or Master’s degree in Life Sciences/Pharmacy/Biotechnology

Job description

Prothya Biosolutions Belgium BV is seeking a Senior QA Officer QMS to reinforce our Quality Assurance team. You will ensure GMP compliance, support QP batch release activities, and uphold high-quality standards across manufacturing operations, working with Manufacturing, Quality Control, Engineering, and Regulatory Affairs.

Key responsibilities include GMP and batch release, QA documentation, deviations and CAPA handling, internal audits and inspections, training, and continuous improvement to