Senior Quality Officer
€4,700 - €6,760 per year
Key Skills
Job Description
Senior Quality Officer Preparation of QP batch release for Products (Quality records, Batch recordreview, release documentation), overall QMS compliance relating to QA Operational tasks. You play a key role in executing structured simple Root Cause Analyses (RCA), tracking CAPA effectiveness, and supporting audit readiness. Your work contributes to maintaining product quality, reducing recurring issues, and ensuring continuous process improvements within the organization. Responsibilities Batch Release Batch record review Preparation for QP batch release (intermediates, Drug Substances, DrugProducts and Finished Products) Supervise QA Officers (or junior personnel in general ) in Communication with OMCL Physical release in the product Warehouse QMS Assessment and review, follow-up and timely closure of minor/major/(Critical if SME) deviations Assist extended Root Cause Analyse (RCA) with known techniques. Assessment and review, follow-up and timely closure of OOS / OOL /OOT records. Assist Quality engineers in Investigation and timely closure of Product Quality Complaints Handling of returned goods Review, follow-up and timely closure of Corrective and Preventive actions (CAPA’s) Execute deliveries from change controls Validation support Review & Approval of routine Equipment validations Inspections SME (Subject Matter Expert) during Self inspection as auditee, and customer audit. Back office in regulatory audit. Support presentation of process in regulatory audits Training On the Job of QA Ops staff in Deviations, CAPA’s the related systems Compliance review Writing of GMP-procedures review and approval of GMP-documents (e.g. GMP-procedures, master batch records) Documentation and reporting Deliver quality raw data for monthly Metrics and Quality Management Review and for Product Quality Review. QA on the shopfloor Perform shopfloor visits People management/ leadership (example) Coach junior member team. Possible project leader if SME. Stakeholder Management (example) Support Quality lead in stakeholder management GxP Takes GxP requirements into account during preparation, execution and reporting of GxP activities. Is fully aware of key SOPs such as procedures for Events, OOS and good documentation practice. Follows mandatory GxP training and maintains an appropriate training record. Identifies and escalates GxP issues. Your Profile: Bachelor/ Academic (master’s degree) in Life Sciences/ Pharmacy HBO > 2yrs experience or young Academic (MSc) Basic knowledge of the GMP-guidelines and experience with biological intermediates, drug substances and aseptic manufacturing preferred. Experience with Trackwise/ Mastercontrol/ SAP or similar. Dutch and English speaking (work proficiency) English writing skills. You naturally take a proactive approach are an analytical thinker and clear communicator What we offer: Salary range € 4.702,26 € 6.759,41 A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly A fulltime employment of 40 hours per week Flexible working hours after deliberation Your own place in a close-knit and expert team with an employer that stimulates growth and personal development Good accessibility by public transport and we provide private parking; Sound pension provision.
Core Responsibilities
Prepare and review batch-release documentation, oversee quality-system records and follow-up, and support investigations, CAPAs, validations, audits, and GMP compliance. Coach junior QA staff, conduct shop-floor visits, and provide quality data and documentation for reporting and product reviews.
Requirements
Requires a bachelor's or master's degree in life sciences or pharmacy, with more than two years of experience for an HBO-level candidate or a master's-level early-career profile. Basic GMP knowledge is expected; experience with biological intermediates, drug substances, aseptic manufacturing, and systems such as TrackWise, MasterControl, or SAP is preferred, along with work-proficiency Dutch and English and English writing skills.
Benefits
- Holiday Allowance
- Year-End Bonus
- Flexible Working Hours
- Personal Development Opportunities
- 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!