Senior Quality Officer QMS
Key Skills
Job Description
About the Role 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.
Core Responsibilities
Ensure GMP compliance and support QP batch release activities for drug substances and products. Manage the Quality Management System by handling deviations, CAPAs, and change controls while overseeing shopfloor QA activities.
Requirements
Requires a Bachelor's or Master's degree in Life Sciences, Pharmacy, or Biotechnology with experience in a GMP-regulated pharmaceutical environment. Must possess strong analytical skills and knowledge of EU GMP guidelines and deviation management.
Benefits
- End-of-year bonus
- Holiday allowance
- Personal training budget
- Travel expense contribution
- Public transport accessibility
- Private parking
- Pension plan
About Prothya Biosolutions
Industry: Pharmaceutical Manufacturing
Company size: 1,001-5,000 employees
Prothya Biosolutions was formed in 2021, when Plasma Industries Belgium (PIBe), with roots in the Belgian Red Cross, integrated with Sanquin Plasma Products (SPP), a former subsidiary of the Sanquin Blood Supply Foundation (Stichting Sanquin Bloedvoorziening). Prothya Biosolutions offers over 60 years of experience in the collection of blood plasma and production of plasma-derived medicinal products, and a long legacy of collaboration, innovation, and delivery of science-based solutions. Thanks to our diverse background, we recognize the unique value of plasma-derived medicinal products for people and society, and reflect this in our ongoing transformation into a results-driven and global organization. Stable plasma derivatives such as clotting factors, immunoglobulins and albumin solutions are produced with the fractions isolated by Plasma Industries. At Prothya, we believe the best medicines are already in your body. The human plasma proteome holds the promise of a revolution in disease diagnosis and therapeutic treatment. We will continue to play a leading role in discovering how the abundance and structure of proteins can change the way we treat human diseases. Prothya Biosolutions processes around 3 million liters of plasma each year for several international partners. This change in focus entailed a change in corporate culture. Prothya has a clear vision we call DRIVE, embodying the core values on which our organization is founded. Do you want to play an active role in improving the health of millions of patients? Would you like to be our partner or future colleague at the forefront of new developments in the Protein Therapy Development, Processing and Manufacturing? Then you are welcome at Prothya Biosolutions!