QA Engineer – Equipment & process qualification

QA ENGINEER – EQUIPMENT & PROCESS QUALIFICATION

The company is an innovative molecular diagnostics company committed to revolutionize molecular testing. They provide next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and the healthcare industry, with a focus on oncology.

The company’s proprietary molecular diagnostics platform is a fully automated sample-to-result, real-time PCR system that offers accurate, highly reliable molecular information from virtually any biological sample, in virtually any setting, allowing fast and effective treatment selection and treatment progress monitoring.

The key mission of the QA Engineer II – Equipment & Process Qualification is

• to provide compliance related guidance on equipment qualification & process qualification processes
• to be accountable for the approval of qualification related deliverables

The QA Engineer II – Equipment & Process Qualification is responsible to oversee the qualification of Manufacturing/QC/Development/Engineering equipment and processes. This to ensure that all qualification/validation related processes are described in compliance with the current applicable regulations and that related activities are performed and recorded accordingly.

The role includes, but is not limited to, the following accountabilities:

• Support the continuous improvement of the qualification approach through SOP’s (Standard Operation procedures) and Work instructions and ensure that equipment & process qualification processes are compliant with current regulations;
• Review and support the planning, coordination, execution and follow-up of equipment & process qualification activities;
• Contribute to maintaining and periodically evaluating the qualified state of equipment, systems and processes;
• Ensure timely completion of assigned Corrective Actions & Preventive Actions related to equipment, facilities & utilities;
• Maintain a current knowledge of international regulations, guidelines (e.g. ISPE) and new evolutions related to Qualification through courses, conferences, seminars, internal and external benchmarking and literature. This to maintain and improve qualification processes in view of industry & regulatory expectations and securing compliance;
• Act as QA spokesperson (auditee) during first-party, second-party and third-party audits for qualification of Manufacturing/QC/Development/Engineering equipment & processes.

• Master Degree in engineering, chemistry, pharmacy or equivalent through experience;
• At least 5 years of experience in the Life Sciences industry of which minimum 2 years in a Quality Assurance role;
• Experience with the concepts, legislation and requirements related to qualification of processes, equipment and systems, including ALCOA+ (data integrity), Part/Annex 11(electronic records & signatures) and current Good Manufacturing Practices;
• Experience in technical writing and Good Documentation Practices;
• Self-propelling and flexible;
• Experience with IVD manufacturing processes, preferably in the field of nucleid acid related products (Biochemical processes) is an asset;
• Legislation and regulation:
  • ISO 13485 – Medical devices — Quality management systems — Requirements for regulatory purposes
  • 21 CFR Part 820 – Quality System Regulation (Medical Devices)
  • 21 CFR Part 11 – Electronic Records, Electronic Signatures
• Guidance:
  • ISPE GAMP 5 A Risk-Based Approach to Compliant GxP Computerized Systems
  • ISPE Science and Risk-Based Approach for the Delivery of facilities, Systems, and Equipment
• Analytical thinking: Conducts ongoing in-depth analysis to anticipate potential problems and guides others in complex issues;
• Planning and Organization: Expert – Time & priority management: plans activities effectively with respect for priorities and deadlines.;
• Communicating & Influencing: Expert – Communicates with persuasion: presents, explains and defends a complex message in a clear and concise way and persuades different stakeholders;
• Adaptability to change: Expert – Adapting to change: accepts and implements change and adapts, even in difficult situations;
• Resilience: Expert – Continues to perform effectively under time pressure and in the face of disappointment, adversity and opposition;
• Coaching & Development: Expert – Provides constructive feedback, takes an exemplary role towards learning, guiding and mentoring colleagues;
• Software and database applications:
  • MS Office (Word, Excel, PowerPoint and Outlook)
  • Statistical process control applications;
• Languages: good knowledge, orally and in writing, of Dutch and English.