Validation Engineer - Lab Devices (GMP)

Recruit Express Pte Ltd| Date Posted: 10-Jul-2020
EA Licence No: 99C4599|EA Personal Registration No: R1333338
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Job Nature:
Permanent
Position Level:
Experienced
Qualification:
Diploma, Bachelor's / Honours

Job Description

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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