Qc Csv Engineer - Singapore - NUSANTARA PRIME CONSULTING PTE LTD

NUSANTARA PRIME CONSULTING PTE LTD

Verified Company

Singapore

1 week ago

Posted by:

Wei Jie

beBee Recruiter

Description

Responsible to deliver and ensure successful qualification of 2 types of new QC lab equipment with computerized software (2units each) within the targeted schedule.

Responsibilities:

Responsible for managing and writing of qualification related documentation but not limited to Qualification Plan and IQ, OQ, PQ and ERES Test Scripts for QC laboratory equipment (lab bench and CSV system)
Responsible for overseeing execution of but not limited to IQ, OQ, PQ and ERES Test Scripts of QC laboratory equipment (lab bench and CSV system) and test script for new equipment deployments.
Manage and maintain the progress tracking matrix on document generation, qualification execution, document review and approval. Escalate the issue/delay to management team.
Coordinate and manage deviation to be initiated, assessed and closed out in timely manner.
Responsible for stakeholder management including coordination with QC lab team on equipment availability for qualification activity.
Responsible for all other activities related to qualification activities but not limited to change control, tag out, PM/Calibration program, equipment configuration, SOP generation.
Work with IT team to develop the CSPECs, ERES etc to fulfill Part 11 requirement.
Responsible for managing computerized system validation lifecycle data integrity portion and risk assessment.
Handover and coordination post LEQ execution to QC lab
Any other task as assigned by Supervisor/Manager

About You:

Bachelor in Engineering, Sciences, Business, Information Systems or equivalent. Min 5 years of experience in QC Lab Equipment Qualification in pharma or biotech facility.
Knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility
Good interpersonal, communication and presentation skills.
Must be a selfstarter, fast learner, curious with strong analytical and organizational skills
Selfmotivated and willingness to learn
Reliable and Responsible