Overview
Quality Assurance Analyst Jobs in Bilthoven, Utrecht, Netherlands at Alphasqmax
Title: Quality Assurance Analyst
Company: Alphasqmax
Location: Bilthoven, Utrecht, Netherlands
Key Responsibilities
Analyze assigned samples using chromatographic tests and calibrated instruments to ensure compliance with set specifications and standards.
Perform analysis for the release of Finished Products (FP) as per committed timelines.
Independently handle instrumental analysis, including HPLC, GC, FTIR, UV, etc.
Conduct FP sample analysis as per schedule and evaluate test results against specifications.
Adhere to Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
Document all activities online using approved formats/templates to ensure accuracy and authenticity.
Maintain system integrity by updating documentation and deviations during operations.
Ensure all online documentation and supporting records are maintained accurately and in a timely manner.
Prepare new documents and update existing ones as per Good Manufacturing Practice (GMP) requirements.
Maintain laboratory cleanliness by disposing of analyzed solutions and samples following proper disposal procedures.
Foster effective communication and collaboration within the team and with internal/external stakeholders.
Maintain equipment, facility, and block premises as per Standard Operating Procedures (SOP).
Perform validation, qualification, and calibration as per schedule and update relevant records.
Ensure compliance with all standard operating procedures, GMP, GLP, and safety norms.
Gather samples for analysis and verify consignment details for sampling.
Prepare required standards, glassware, and solvents for analysis as per specifications.
Operate instruments and perform activities as per SOP and safety guidelines.
Participate in GMP and customer audits.
Identify opportunities for cost savings and process improvements.
Conduct operational studies to identify areas for improvement and implement new development projects.
Work towards continuous automation of processes through the implementation of new systems.
Major Challenges
Delays in analysis or re-planning due to frequent changes in schedules – Addressed through performance dialogues and priority-setting meetings.
Instrument breakdowns affecting laboratory activities – Mitigated by ensuring timely availability of spare parts and service engineers.
Delays in batch releases due to unavailability of standards, glassware, or chemicals – Resolved through effective coordination and escalation.
Key Interactions
Internal:
Lab Planning for daily release coordination
QA for handling non-conformances
Lab Assistants for chemical and standard needs
External:
Service Engineers for instrument maintenance and breakdown resolution
Performance Metrics
Number of Finished Product batches released: 5 batches per month
Non-conformance OOS/OOT closure within 7 working days
Maintain minimal non-conformance incidents during sample testing
Maintain professional and cooperative relationships with colleagues
Keep non-conformance rates below 1.5%
Decision-Making & Recommendations
Timely reporting of any non-conformances to the supervisor for appropriate action.
Providing suggestions for improving Quality Control (QC) productivity to the Head of QA/QC.
Recommending procurement of required instruments, glassware, and standards.
Contributing ideas for work simplification and efficiency.
Skills & Qualifications
Education:
B.Sc. in Chemistry or Bachelor of Pharmacy
In Dutch terms:
Secondary vocational education (MBO) with 5+ years of experience
Higher professional education (HBO) with 1-3 years of experience
Experience:
1-3 years in the Quality Control function of a pharmaceutical organization
