About the role

AI summarised

The QMS Specialist I supports quality assurance operations in a GMP environment by managing quality management systems, ensuring regulatory compliance, and driving continuous improvement. Responsibilities include maintaining QMS platforms like TrackWise, overseeing change control and CAPA systems, managing document and training systems, and supporting audit readiness. The role requires collaboration with cross-functional teams to uphold quality standards and support site compliance initiatives.

Life SciencesOnsite

Key Responsibilities

Responsible for writing relevant procedures and reviewing all SOPs from other functional teams
Ensure QMS system (e.g. TrackWise, eDMS, SFLMS etc.) is configured and maintained to support GxP compliance. Authors SOPs / Work Instructions related to QMS
Maintain site change control system, develop effective change control evaluation methodology, oversee and coordinate the execution of site change control procedure, to ensure all changes which will potentially impact product quality are appropriate evaluated and effective controlled
Maintain site CAPA system, including but not limited to designing effective actions and effectiveness check methodology, ensure actions completed on time, and coordinate effectiveness check for actions
Manage corporate standards gap assessment at site level, ensure site practice compliant with regulatory requirements
Maintain document and record management system, develop department document control and cross function document champion team, oversee and coordinate the effective execution of site document management requirements.
Ensure document execution compliant with site management requirements, guide and oversee supplier for record archival, ensure all C&Q executed records are archived
Develop annual training plan. Introduce, develop and improve site GMP training modules
Execute site self-inspection program, to ensure site practice compliant to cGMP and corporate policies, and work on continues improvement of site compliance
Coordinate and complete Inspection readiness activities to ensure site ready for both client and regulatory audits at all times
Participate in hosting client and regulatory audit, responsible for timely and effective execution of external audit commitments
Support site management review process, collect quality data, analyze compliance performance trend, be able to identify and manage the metrics, and responsible for continues improvement

Requirements

Bachelor’s Degree in Life Sciences or Chemical/Biochemical engineering, Pharma related Scientific Area
1 - 3 years of relevant Quality experience in pharmaceuticals preferred. Fresh graduate with relevant qualifications may also be considered
Experience in Quality Management System, Track Wise specifically an asset
Experience in biologics and aseptic training is an asset
Experience in site data integrity management is an asset
Knowledge in cGMP and Regulatory Compliance and GMP Quality Management System
Effective Systematical Thinking and Communication ability
Good Coordination and Collaboration
Effective execution and result driving
Good at problem solving and Quality Risk Management knowledge and tool