Quality Assurance Specialist

at  Merck

Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That’s why we are always looking for curious minds that see themselves imagining the unimaginable with us.

YOUR ROLE

Quality Assurance Specialist is to promote and integrate quality into every aspect of our BioReliance® biologics safety testing business in Singapore. The role is to perform batch record review (i.e. data audits) to support all aspects of quality operations to ensure that laboratory testing operates in full compliance with sound scientific practice, GxP and Standard Operating Procedures (SOPs). The scope of responsibility is to contribute or impact the results of the QA team and is accountable for the quality of own work, solve problems of low complexity independently by identifying and selection solutions and by analyzing information.
The post holder will be able to perform the following functions independently, with minimal guidance.

WHAT YOU DO

• Batch record review:Review and approval of GxP documents, including Protocols, Technical Specification (TS), Batch Records, Workbooks, SOPs and all other QMS documentation.

• Batch record review:Comply with all applicable policies, procedures and guidelines.

• Batch record review:Conduct in-process or final audits and approval on manufacturing or testing documentation as they comply with the stated regulatory standards and the approved TS, protocol or SOPs.
• Batch record review:Release of the certificate of analysis for GMP testing against the TS and associated documentation.
• Batch record review:Prepare QA statement within each GLP final report specifying inspections date, and dates findings were reported to the Study Director and management.
• Review and approve deviations, anomalous results, OOS, positive results and CAPAs.
• Assist in investigations from events, complaints or data audits.
• Conduct trend analysis for deviations and review / approve applicable CAPA records.
• Assist self-inspections to ensure continuous improvement.
• Perform and support client audits, regulatory inspections.
• Perform and support internal audits.
• Perform and support supplier audits.
• Comply with Health and Safety Executive regulations and undergo relevant training modules when required and actively takes necessary action when encountering unsafe situations.
• Perform their duties according to the principles of Good Laboratory (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).

The above list of job duties is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post.