QA Quality Steward: GMP, Data Integrity & Compliance

West Pharmaceutical Services, Inc; Singapore; On-site; SGD 90,000 - 140,000; Full time

Job summary

West Pharmaceutical Services, Inc. in Singapore seeks a Quality Assurance professional to oversee plant operations and laboratory processes, ensuring strict adherence to cGMP, regulatory requirements, and corporate policies.

The role emphasizes sustained data integrity and timely CAPA closure while supporting continuous improvement initiatives. Responsibilities include method validation and transfer, instrument qualification oversight, data audits of electronic records, change control in SAP,

Qualifications

• Bachelor’s degree in Engineering or Science or related discipline.
• Working knowledge of ISO 15378 and ISO 9001 or equivalent quality standards.
• Good understanding of cGMP requirements and quality mindset.

Responsibilities

• Maintain cGMP compliance within laboratories and QA processes.
• Provide GMP support for method validation, transfer, instrument qualification, and verification of compendial methods.
• Provide training on GMP topics and CAPA management.
• Oversee data integrity initiatives and periodic reviews of electronic records and lab data.
• Lead Change Control processes, review and process change requests in SAP, monitor trends, and support product disposition decisions.
• Monitor product quality, perform annual product review, and support technology transfer projects.
• Contribute to Lean Sigma programs and shopfloor audit activities.

Skills

cGMP knowledge

Regulatory compliance

Data integrity

Audit support

CAPA management

Statistical trending

SAP change control

Education

Bachelor’s degree in Engineering or Science

Tools

SAP

Job description

West Pharmaceutical Services, Inc. in Singapore seeks a Quality Assurance professional to oversee plant operations and laboratory processes, ensuring strict adherence to cGMP, regulatory requirements, and corporate policies.

The role emphasizes sustained data integrity and timely CAPA closure while supporting continuous improvement initiatives. Responsibilities include method validation and transfer, instrument qualification oversight, data audits of electronic records, change control in SAP,