Job Scope
- Responsible to review and approve master batch records and subsequent batch records
- Review and approve cleaning records and procedures and ensure compliance with set
- Review and approve GMP documentation Ensure adherence to quality procedures, regulatory requirements and cGMPs.
- Review and approve deviations according to the site procedures
- Handle product complaints.
- Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
- Coordinate with cross-functional team to prepare Annual Product Reviews, discuss trends and atypical observations and recommend improvement actions.
- Conduct internal and external audits
- Maintain inspection readiness and support inspections from regulatory agencies and customers.
- Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
- Support the maintenance of validated stated of GMP systems and processes.
- Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner
Requirements
- A Bachelor Degree in Science / Chemical Engineering or equivalent with relevant biopharmaceutical/ pharmaceutical experience.
- Minimum 2 relevant years of experience in QA/QC and GMP Compliance
- Familiar with manufacturing operations applications six sigma and lean principles and process improvement tools.
- Thorough knowledge of GMP compliance regulations, ICH Q7a Guidelines, Good Documentation Practices and other applicable regulations.
- Proven track record of continuous improvement in quality operations or manufacturing.
All qualified applicants, please send in your resume to:
[Confidential Information]
Tricia Celestine Goh (R1981653)
Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599
