Hobson Prior is currently seeking a Quality Engineer to join a multinational biopharmaceutical company based in Belgium. In this position you will be responsible for assuring that all technical operations related to the production and analysis of pharmaceutical products comply with applicable regulations and guidelines.
- Ensure communication of compliance status and issues to appropriate levels of the organization.
- Contribute in the preparation for regulatory inspections and provide direct support to System Owners and main customers during inspections.
- Co-operating with System Owners, ensure direct follow-up of Compliance Audit activities, Deviations, Failure Investigations, Change Control, Qualification/Validation activities and documentation approval related to automation processes & systems and metrology/ calibration & Periodic controls activities.
- Be the QA Representative for all the local automated & computerized system for Computerized Systems and Automation.
- Lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP.
- Can make quality/compliance decisions in a business environment.
- Stress resistant.
- Strong team player attitude with excellent interpersonal relationship and communication skills.
- Excellent oral and written communication skills.
- Self-sufficiently identify problem situations, communicate appropriately and initiate problem-solving process.
- Excellent organization, ability to balance multiple priorities, provide leadership and prioritization, and work with minimal supervision.
- Master’s Degree or bachelor’s Degree in Chemistry, Biology or related field.
- Minimum of 3 years in a regulated pharmaceutical environment or other life science or health related field, including experience in Quality Assurance and/or Qualification & Validation or Automation fields.
- Prior experience with Quality Management System of automated systems, GAMP practical application and Internal/External Auditing.
- A good understanding of worldwide regulations pertaining to cGMP and Quality Management System requirements.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.