QA Specialist (PHARMA MNC) #HJH

Working Days & Hours: Mon-Fri Office Hours

Responsible for timely archiving or records, checking for good documentation practices and data integrity.

Participate in the preparation of records and QA files in preparation for sponsor site visits and regulatory inspections. May participate in the support of client site visits.

Supports change management processes including monitoring of activities, action verification and its due date and working closely with other departments to ensure timely completion of actions.

Supports the quality system operations such as monitoring of investigation due dates, CAPAs, Internal audit completion, test protocol approvals and working with other department to ensure timely closure or extension.

Review quality records such as logbooks and manage its issuance.

Approve customer test reports and participate in reagent, equipment and facility release activities to support laboratory operations.

Assist in monitoring and verifying training and document management activities.

Performs all functions as tasked with high degree of accuracy and strict adherence to company’s quality requirements.

Maintains proper records and documentation of activities that are compliant with good documentation practices, continuous compliance ISO/IEC 17025, cGMP, PIC/S, Company global SOPs and data integrity principles for all activities.

Assists in quality system projects that involved system implementation for cGMP compliance

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Hazel Huang Huimin

Recruit Express Pte Ltd EA

Licence No: 99C4599

CEI Registration Number: R26163596