Overview
Senior Quality Officer Jobs in Amsterdam, North Holland, Netherlands at Prothya Biosolutions
Title: Senior Quality Officer
Company: Prothya Biosolutions
Location: Amsterdam, North Holland, Netherlands
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:
- A market-rate salary
- 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.
