Job Role: QA Engineer
About the Role
We are seeking an experienced QA Engineer to join our Quality Assurance team in Beerse, Belgium. This role focuses on qualification, calibration, maintenance, and system data governance within pharmaceutical manufacturing, ensuring compliance with quality and regulatory standards. You will review and approve qualification documentation, support change control and system introduction projects, and act as a key representative during audits and inspections.
Key Responsibilities
* Review and approve qualification documentation (Impact Assessments, URS, DQ/IQ/OQ/PQ protocols & reports, QSRs, traceability matrices, etc.).
* Ensure compliance of qualification activities and integration of quality standards into risk-based design reviews.
* Review and approve calibration and maintenance records, certification master data, and system-related procedures.
* Evaluate deviations, investigations, and CAPAs, ensuring effective corrective and preventive actions are implemented.
* Review and approve Periodic System Quality Reviews (PSQRs) and Validation Master Plans (VMPs).
* Ensure qualification deliverables are implemented into quality systems (SOPs, Work Instructions, Calibration Records, Maintenance Plans, etc.).
* Support regulatory and customer inspections, acting as spokesperson for QA qualification-related matters.
* Collaborate with cross-functional teams on system introduction, changes, and qualification projects to ensure compliance and timelines are met.
* Drive continuous improvement and optimization of qualification processes.
Key Competencies
* Strong knowledge of pharmaceutical legislation, cGMP regulations, and system qualification guidelines.
* Analytical thinking, problem-solving, and risk assessment skills.
* Effective communication and collaboration across teams and departments.
* Ability to manage complexity, multiple priorities, and cross-department objectives.
* Proactive mindset for innovation and continuous improvement.
Specific Know-How of Systems
* Comet – incident handling and control of change system.
* eStream – computerized maintenance management system.
* TrüVault – document management system.
* Summit – training system.
* Kneat – digital validation lifecycle management.
Requirements
* Master’s Degree in Engineering, Pharmacy, or equivalent.
* 5+ years of experience in the pharmaceutical industry.
* Fluency in Dutch and English (written and spoken).
* Familiarity with systems used in pharmaceutical manufacturing processes.
Practical’s
* Location: Beerse, Belgium
* Duration: end of 2025 (with potential extension)
* Start Date: ASAP
* Work Model: Full-time, Hybrid
Interested or know someone who might be?
Send your CV or inquiries to e.cabral@panda-int.com to apply or learn more.