QA Associate

Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Our Singapore facility is a strategic hub in the Asia Pacific region with 22+ years of expertise in the import/export, secondary packaging and labeling of clinical supplies, cold chain handling of temperature sensitive products, and full returns and destruction management.

Summary of essential functions:

To provide quality support to the Clinical Storage and Distribution facility in Singapore in line with PIC/S Good Manufacturing Practice and Good Distribution Practice. (GMP and GDP)

What you will be doing:

• Provide support on Quality matters to Project Management / Operations in secondary packaging, storage and distribution of investigational materials.
• Co-ordinate and host client audits and regulatory inspections.
• Consolidation and provision of response reports for client audits and regulatory inspections.
• Review and approve complaint, non-conformance and deviation reports.
• Monitor and close corrective and preventive actions from client audit, regulatory inspections, complaints, non-conformance and deviation reports.
• Collate and trend metrics from quality issues (audits, complaints, non-conformances etc).
• Manage of SOP System and records retention.
• Review and approve qualification/ validation documents.
• Conduct GMP/ GDP training as required.
• Manage supplier and contractor evaluation program.
• Manage internal audit program and perform internal audits.
• Review and approval of batch records.
• Perform inspection and in-process checks.
• Co-ordinate product recall and mock recall exercise.
• Provide regulatory support for operations.
• Perform duties as an Authorized Person
• Multi tasked in Quality Assurance functions in providing services to Singapore Depot Operations.
• Pursuant to Annex 13 of PIC/S GMP Guide to Good Manufacturing Practice for Medicinal Product Part 1, assess and ensure that each batch has been manufactured and checked in accordance with standard of good manufacturing practice.

What we are looking for:

• Diploma in Engineering / Quality 
• 5 years experience in quality functions
• A robust track record in operational quality management and delivery in an environment of business development and change is essential.
• An experienced people leader with a track record of Quality Assurance.