Job Responsibilities
- Develop, review and maintain Quality Management System (QMS) procedures, SOPs and Work Instructions to ensure compliance with GxP requirements.
- Manage the site Change Control system, ensuring proposed changes are appropriately evaluated, documented and controlled for potential product quality impact.
- Maintain the CAPA system, including action planning, tracking, effectiveness checks and timely closure.
- Conduct gap assessments against corporate quality standards and regulatory requirements.
- Manage document and record control processes, including document lifecycle management and archival of quality and qualification records.
- Maintain the GMP training system, develop annual training plans and support the development and improvement of GMP training modules.
- Coordinate personnel training and qualification activities across functions.
- Develop and execute Annual Product Quality Review plans, including trend analysis and implementation of CAPAs where required.
- Support the site self-inspection programme, including audit planning, execution, periodic reviews and trend analysis.
- Coordinate inspection readiness activities to ensure continuous preparedness for client and regulatory audits.
- Provide quality oversight for supplier management activities, including Quality Agreements, supplier change controls and supplier evaluation.
- Maintain and support site Data Integrity requirements and ensure effective implementation across functions.
- Promote compliance with site safety requirements, emergency procedures and safe systems of work.
Requirements
- Diploma or Degree in Life Sciences, Pharmaceutical Sciences, Chemistry, Biotechnology or a related discipline.
- Relevant experience in Quality Assurance, Quality Systems or QMS within a pharmaceutical, biopharmaceutical or other regulated environment.
- Experience with Change Control, CAPA, document control and quality event management.
- Good analytical, problem-solving, communication and stakeholder management skills.
- Able to work independently while coordinating effectively with cross-functional teams.
Interested candidates are invited to email your resume to:
[Confidential Information]
Jenalyn Ooi Huai Sian (R1765551)
Recruit Express Pte Ltd
Company Reg. No. 199601303W
EA Licence No. 99C4599
