Quality Engineer

工作内容

Quality Engineer

Role:

• Responsible to integrate quality standards to mitigate failure mode risks during risk-based assessments in the asset management design reviews
• Ensure compliance of qualification activities.
• Review and approval of qualification documents.
• Review and approval of calibration and maintenance records
• Review and approval of 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
• 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 (IA), 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 the clients 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.

cGxP / ATMP

• Always uses the appropriate cGxP and procedures.
• Reports incidents and deviations.
• Proposes solutions to improve compliance with cGMPs.
• Safety, Health & Environment (SHE)
• 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 actively on promotion campaigns, working on the safe behaviour program, prevention controls.
• Addresses to other colleagues and third persons when prevention procedures are not followed or in case of unsafe behaviour.

Experience:

• Senior: 5 years experience in the Pharmaceutical industry
• Fluent in Dutch and English (written and spoken)
• Master 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
• TrüVault: document management system
• Summit (training system)
• Kneat