Quality Assurance Manager Beerse, Belgium

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

Clin Choice, is searching for a Quality Assurance Manager to join one of our partner companies, a large pharmaceutical company, leader in the field of biomedicines, where you will work in a hybrid model in Beerse for 15 months.

Clin Choice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

• Responsible to integrate quality standards to mitigate failure mode risks during risk-based assessments in the asset management design reviews.
• Responsible for ensuring compliance with qualification activities.
• Responsible for reviewing and approval of qualification documents, calibration and maintenance records, certification master data.
• Responsible for review and approval of master data E6 notifications (eStream), change controls records and quality issue/investigation records, including corrections and CAPAs during execution of qualification activities and during the life cycle of the facility, system and equipment.
• Maintain a current knowledge of international regulations, guidelines and industry practices related to system qualification and system data governance
• Participate in system introduction and system change projects and assure quality and compliance aspects.
• Assuring that the qualification status is maintained during assessment and execution of changes and projects
• Ensuring that all system changes that may have impact on quality, compliance or registration, are evaluated and approved in order to execute adequate control, documentation and qualification.
• Review and approval of qualification documents such as (system level) Impact Assessment critical aspect risk assessments (General) User Requirements ((G)
  URS), DQ/IQ/OQ/PQ protocols & reports, QSR, Test- and traceability matrices, …for compliance to regulations, guidelines and Company procedures.
• Review and approval of Periodic System Quality Reviews (PSQR) and Area Validation Master Plans (VMPs)
• Ensuring that deviations related to systems (qualification, maintenance, calibration and/or use) with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and preventive actions are implemented.
• Responsible for review and approval of calibration/certification procedures, calibration rationales, calibration master forms and completed calibration records.
• Responsible for review and approval of preventive maintenance procedures and master forms.
• Responsible for review and approval of parameter lists, alarm lists and transmission lists and other documents in eSTREAM
• Responsible for review and approval of qualification / system related procedures/work instruction.
• Make sure that all deliverables out of qualification are implemented in the quality systems: SOPs, Work instructions, Calibration records, Maintenance plans, …
• Prepare for regulatory and customer inspections and act as a spokesperson for QA qualification related matters during audits.
• Interact regularly with other functional groups/departments involved in qualification projects to assure that timelines for system qualifications are met and the cross-department objectives are realized.
• Pro-actively and continuously challenge the quality of the qualification processes to improve the performance of qualification and develop and implement improvements.
• Always uses the appropriate cGxP and procedures.
• Reports incidents and deviations.
• Proposes solutions to improve compliance with cGMPs.
• Always uses the appropriate prevention rules and procedures.
• Uses the available personal and collective protection materials correctly.
• Works neat and tidy.
• Reports (near) accidents, incidents, deviations and risky situations.
• Cooperates on and suggests solutions to improve safety, health and environment.
• Participate…