Validation Engineer - Lab Devices (GMP)
Recruit Express Pte Ltd
Singapore, Singapore
5d ago
source : CareerBuilder

Equipment, Facility, Safety and Cost Management / Support Update or monitor the Master Schedule and Equipment Control Database for equipment related activities to ensure that equipment activities are performed according to SOP.

Schedule, coordinate and supervise periodic maintenance, repairs and calibration of equipment, instrumentation, and critical utilities a, which may include liaising external vendors.

Schedule and oversee internal IOPQ activities and verification activities, where needed, for new equipment and instrumentation in compliance to ICH, CGMP, and ISO / IEC 17025 guidelines.

Manage facility maintenance activities including performing risk assessments and coordinating with external vendors e.g.

pest control programmes, Continuous Monitoring System (CMS), biohazard & chemical waste management programmes, etc. Perform and / or review risk assessment where applicable Manage and trend safety incidents for the site.

Document Management Conduct periodic amendment, reviews or harmonisation of SOPs for relevance, fitness-of-use, optimisation and compliance to appropriate regulations for equipment-, and instrumentation- matters.

Responsible for drafting new SOPs pertaining to equipment use and facility operations. Ensure completion, maintenance and archival of completed qualification protocols and / or service reports Maintains documentation on new / existing laboratory equipment, repairs and failures.

Support procurement activities within area of responsibility. Coordinate, conducts meeting and negotiate with vendors via period contracts or maintenance contracts to obtain competitive pricing for the subcontracted area of work.

Assist and support manager in budgeting and planning for the department. Quality Provide support to manager and QA department during regulatory and internal / client audits.

Prepare or review change management and other appropriate quality assurance documents in the event of critical / major change in equipment, instrumentation and facilities.

Maintain or review appropriate records and documentation of activities to facilitate continuous compliance to ISO / IEC 17025, CGMP, PIC / S, Company local and global SOPs and data integrity principles.

Requirements Possesses at minimum, a degree in Engineering, Biomedical Sciences or any related field. Minimum 1 years of relevant experience in an ISO17025 / GMP environment is preferred.

Min 1 to 2 years of experience in validation Office Hours Monday to Friday $3.2K to $4K Interested candidates, please forward your resume to Click Here to Email Your Resume Consultant : Huang Jingsheng Kevyn (R1333338) Recruit Express Pte Ltd (99C4599)

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