Responsible for integrating quality standards to mitigate failure mode risks during risk-based assessments in asset management design reviews.
* Ensure compliance of qualification activities.
* Review and approve qualification documents.
* Review and approve calibration and maintenance records.
* Review and approve certification master data.
* Responsible for reviewing and approving master data E6 notifications (eStream), change control records, and quality issue/investigation records, including corrections and CAPAs during qualification activities and the lifecycle of the facility, system, and equipment.
* Maintain current knowledge of international regulations, guidelines, and industry practices related to system qualification.
* Participate in system introduction and system change projects, assuring quality and compliance aspects.
* Ensure that qualification status is maintained during assessment and execution of changes and projects.
* Evaluate and approve all system changes that may impact quality, compliance, or registration to execute adequate control, documentation, and qualification.
* Review and approve qualification documents such as (system level) Impact Assessment (IA), critical aspect risk assessments, (General) User Requirements ((G)URS), DQ/IQ/OQ/PQ protocols & reports, QSR, Test- and traceability matrices for compliance with regulations, guidelines, and client procedures.
* Review and approve Periodic System Quality Reviews (PSQR) and Area Validation Master Plans (VMPs).
* Ensure 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.
* Review and approve calibration/certification procedures, calibration rationales, calibration master forms, and completed calibration records.
* Review and approve preventive maintenance procedures and master forms.
* Review and approve parameter lists, alarm lists, and transmission lists, and other documents in eSTREAM.
* Review and approve qualification/system-related procedures/work instructions.
* Ensure that all deliverables from 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 ensure that timelines for system qualifications are met and cross-department objectives are realized.
* Proactively and continuously challenge the quality of the qualification processes to improve performance and implement improvements.
cGxP / ATMP
* Always use the appropriate cGxP and procedures.
* Report incidents and deviations.
* Propose solutions to improve compliance with cGMPs.
* Always use the appropriate prevention rules and procedures.
* Use available personal and collective protection materials correctly.
* Work neat and tidy.
* Report (near) accidents, incidents, deviations, and risky situations.
* Cooperate on and suggest solutions to improve safety, health, and environment.
* Participate actively in promotion campaigns, working on the safe behavior program, prevention controls.
* Address other colleagues and third persons when prevention procedures are not followed or in case of unsafe behavior.
Experience:
* 5 years of experience in the Pharmaceutical industry.
* Fluent in Dutch and English (written and spoken).
* Master's in Engineering, Pharmacy, or equivalent degree.
* Thorough knowledge of pharmaceutical legislation, cGMP regulations, and guidelines in the area of system qualification.
* Knowledge of the different systems used during the manufacturing process.
* Strong analytical thinking, risk assessment, and communication skills.
* Collaboration and teaming skills.
* Mindset for innovation and optimization.
Specific know-how of systems:
* Comet system for incident handling/control of change.
* eStream: computerized maintenance management system.
* Kneat.
Seniority level
Associate
Employment type
Full-time
Job function
Product Management, Science, and Production
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr