Contract: 1 year contract (extendable)

Location: Buona Vista

Working Hours: can plan working schedule with supervisors, 3-4 days/week

Pay: 20/hr

Job scope

• 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.
• Utilises various software applications, such as spreadsheet, relational databases, and electronic mail, to assemble or format data or test reports.
• Performs entry and verification of data in laboratory systems and equipment.
• Ensures quality control processes are adhered to and maintained.
• Ensures asset protection.
• Liaises with IT and CRU personnel for any IT related equipment and system needs.
• Ensures activities are in compliance with internal and regulatory requirements.
• Ensures good documentation practices are met.
• Familiar with CSQ policies, procedures, SOPs and regulatory requirements for laboratory systems and equipment.
• Orientates, train and coach new CRU personnel on equipment handling and operations.
• Acts as a technical resource within the CRU.
• Contributes to a positive work environment by demonstrating excellent interpersonal and communication skills.
• Actively participates in individual performance management plan and yearly performance and developmental planning to support corporate priorities and business goals.

Job requirements

• Diploma in Life Sciences, Engineering, Information Systems or Computer Systems.
• Preferable with biomedical and/or clinical research experience.

Interested candidates, do submit your resume in Word document to: biopharma@recruitexpress.com.sg

Whatsapp https://wa.me/6587514779

Jocelyn Chan          

Recruit Express Pte Ltd (Healthcare & Lifescience)          

Company EA Licence number : 99C4599          

Personnel EA License: R1331820