Senior Quality Officer QMS

Prothya Biosolutions; Amsterdam; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

8.33% end-of-year bonus

8.33% holiday allowance

Personal training budget of €2,100

Contribution to travel expenses

Pension plan

Excellent public transport accessibility

Job summary

Prothya Biosolutions in Amsterdam is searching for a Senior QA Officer to ensure GMP compliance and maintain high-quality standards in manufacturing operations. You will collaborate with various teams to support quality assurance activities and regulatory inspections.

The ideal candidate holds a degree in Life Sciences and has relevant experience in QA Operations. We offer a challenging work environment with bonuses, travel contributions, and professional development opportunities.

Qualifications

• Experience in GMP-regulated pharmaceutical or biotechnology environment.
• Experience in QA Operations, Batch Release, or Quality Systems preferred.
• Knowledge of EU GMP guidelines.

Responsibilities

• Prepare QP batch release documentation for intermediates and drug products.
• Conduct batch record reviews and approvals.
• Act as Subject Matter Expert during internal audits and inspections.

Skills

Analytical skills

Problem-solving skills

Communication skills

Detail-oriented

Stakeholder management

Education

Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field

Job description

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

• 8.33% end-of-year bonus and 8.33% holiday allowance.
• 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.