Senior Quality Officer QMS

Prothya Biosolutions Belgium BV; Netherlands; Teletrabalho; EUR 52 000 - 75 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

30 holiday days

Training budget €2,100 every 3 years

Travel expense reimbursement

Pension plan

Public transport access

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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

Conhecimentos

Analytical thinking

Problem solving

Communication

GMP knowledge

QA Operations

Formação académica

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

Descrição da oferta de emprego

Prothya Biosolutions is currently seeking a motivated and detail-oriented Senior QA Officer QMS to join our Quality Assurance team. In this role, you will play a key part in ensuring GMP compliance, supporting QP batch release activities, and maintaining high-quality standards across manufacturing operations. You will work closely with cross-functional teams including Manufacturing, Quality Control, Engineering, and Regulatory Affairs to ensure compliance, continuous improvement, and operational excellence.

Key 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

Quality Management System (QMS)

• Assessment, review, and timely closure of deviations (minor, major, critical where applicable)
• Support extended Root Cause Analysis (RCA) using established methodologies
• Review and closure of OOS, OOL, and OOT investigations
• Support investigations related to Product Quality Complaints
• Handling of returned goods
• Review and follow-up of CAPAs
• Execute and follow up on change controls

Validation Support

• Review and approval of routine equipment validations
• Support validation activities where required

Inspections & Audits

• Act as Subject Matter Expert (SME) during internal audits and customer inspections
• Support regulatory audits and inspection readiness
• Present processes during audits where required

Training & Compliance

• 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)

Documentation & Reporting

• Deliver quality data for monthly metrics and Quality Management Review
• Support Product Quality Review documentation
• Perform routine shopfloor QA oversight visits

People & Stakeholder Management

• Coach junior team members
• Act as project lead where applicable (SME)
• Support Quality Lead in stakeholder management

Requirements

• 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

What We Offer

• Full-time employment (40h) with flexible working hours in consultation. Working part-time can be discussed.
• Salary between€ 4.702,26 and € 6.759,41 gross per month based on full-time employment.
• 8.33% holiday allowance and 13th month payment.
• 30 holiday days.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.