• Establishes, develops, executes and completes installation records, qualification protocols and validation documentation.
• Performs direct installation activities, such as creation, execution and completion of installation records.
• Performs direct qualification activities, such as creation, execution and completion of qualification protocol (QMP, DQ/UR, IO, OQ, PQ and QSR).
• Performs direct validation activities, such as creation, execution and completion of validation documentation (Validation plan, System Overview, Design Specifications, requirements, traceability matrix, Test Plan, Test cases, validation report, etc.) and supporting documents (i.e. Data Flow Diagrams).
• Conducts validation or qualification tests of new or existing processes, equipment, or software, in accordance with internal protocols and where applicable, external standards.
• Conducts routine review of validation or qualification documentation and processes to ensure compliance with internal or regulatory requirements.
• Liaises with external parties on equipment and consumables. This can include quotation request, management of service/maintenance contracts/agreements, repairs and disposal.
• Liaises with internal parties for equipment preventive/corrective maintenance, calibration arrangements, installation, qualification and validation protocol review and approval, processing purchase orders and vendor invoices. This includes:
- Maintaining equipment calibration, preventive/corrective maintenance records.
- Ensuring timely calibration and/or preventive maintenance of equipment.
- Creating and maintaining databases for tracking equipment calibration, preventive/corrective maintenance.
• Generates and maintains study specific equipment lists.
• Maintains the Master Equipment list.
• Tracks equipment issues/problems via an appropriate change control and problem management system.
• Tracks equipment/system changes including but not limited to configuration change, access review or documentation update via an appropriate change and problem management system.
• Creates and maintains database for qualifications, validation activities, test results, or validated systems.
• Plans and projects new equipment needs and old equipment replacement and retirement.
Job Requirements
- Min Diploma in Life Sciences, Engineering, Information Systems or Computer Systems.
- Preferable with biomedical and/or clinical research experience.
We regret that only shortlisted candidates will be contacted
Interested candidates please send your resume to [email protected]
Consultant: Tan Ming Hui, Magdelene (R21101623)
Recruit Express Pte Ltd (99C4599)
