QA Specialist (PHARMA MNC) #HJH

Recruit Express Pte Ltd; Singapore; On-site; SGD 39,000 - 58,000; Full time

Job summary

Recruit Express Pte Ltd is seeking a Quality & Records Specialist to ensure timely archiving, data integrity and compliance with GMP standards.

You will support sponsor site visits, regulatory inspections, change control, CAPAs, internal audits and document management activities with a focus on accuracy and adherence to SOPs.

Qualifications

• Experience with GMP/GLP quality systems is desirable.
• Familiarity with ISO/IEC 17025 and data integrity principles.
• Strong attention to detail and documentation discipline.

Responsibilities

• Archive records timely and ensure good documentation practices.
• Prepare QA files for sponsor site visits and regulatory inspections.
• Support change management processes and monitor action due dates.
• Contribute to quality system operations including investigations, CAPAs and internal audits.
• Review quality records such as logbooks and issue handling.
• Assist in training, document management activities and accuracy in records.
• Ensure records comply with cGMP, PIC/S and company SOPs.

Job description

Working Days & Hours: Mon-Fri Office Hours

Job Description:

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