Senior Quality Officer QMS

Prothya Biosolutions; Amsterdam; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Annual bonus

Holiday allowance

Training budget

Travel reimbursement

Pension plan

Good transport access

Job summary

Prothya Biosolutions seeks an experienced Senior QA Officer QMS to drive GMP compliance, support QP batch release activities, and maintain high-quality standards across manufacturing operations. You will collaborate with Manufacturing, Quality Control, Engineering, and Regulatory Affairs to ensure compliance and continuous improvement.

The role emphasizes QA operations, deviation handling, CAPA, audits, and staff training while coordinating with regulatory bodies to ensure inspection readiness.

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

• Prepare QP batch release documentation for intermediates, Drug Substances, Drug Products, and Finished Products.
• Review and approve batch records.
• Physically release products in the warehouse.
• Ensure overall QMS compliance related to QA operational tasks.
• Supervise QA Officers or junior personnel where applicable.
• Coordinate with OMCL during required communications.
• Support extended Root Cause Analysis (RCA) using established methodologies.
• Review and closure of OOS, OOL, and OOT investigations.
• Assist investigations related to Product Quality Complaints.
• Handle returned goods and CAPA close-outs.
• Execute change controls and monitor related activities.
• Review and approve routine equipment validations.
• Assist validation activities where required.
• Act as SME during internal audits and customer inspections.
• Support regulatory audits and inspection readiness.
• Present processes during audits as required.
• Provide on-the-job training to QA Operations staff and support deviations, CAPA, and quality systems training.
• Write and review GMP procedures and GMP documentation (SOPs, Master Batch Records).
• Deliver quality data for monthly metrics and Quality Management Review.
• Support Product Quality Review documentation.
• Conduct routine shopfloor QA oversight visits.
• Coach junior team members and lead projects as SME.
• Assist Quality Lead in stakeholder management.

Skills

GMP knowledge

QA Operations

Batch Release

Deviations & CAPA

Root Cause Analysis

Documentation

Stakeholder Management

Training

Education

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

Related field expertise

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.