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Quality Management Manager

3 weeks ago

Singapore Tessa Therapeutics Pte Ltd Full time

**Company Background**

**Job Position**
Quality Management Manager
- Executes the assigned Quality Process according to established procedures and requirements
- CMC related activities, manage the change control
- Provides QA oversight of the assigned Quality Process to ensure that products are processed, manufactured, stored and distributed according to applicable current GxP and regulations
- Provides QA oversight of the assigned Quality Process to ensure that facilities, equipment, materials, processes and procedures comply to applicable current GxP and regulations
- Maintains the assigned Quality Process according to applicable current GxP and regulations
- Partners with functions to ensure the assigned Quality Process is executed according to established policies and procedures
- Reviews/approves and provides inputs for procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gap assessments associated with the assigned Quality Process. May also support execution of these tasks
- Ensures deviations from assigned Quality Process are documented and investigated
- Setting up the QMS and documentation control
- Supports inspection and audit preparations
- Participates in inspections, audits and Quality Management Review
- Escalates quality and compliance risks to Head of Department, QA
- Supports improvement initiatives, programs and projects of the assigned Quality Process

**Requirements**:

- Advanced Degree/Degree, Diploma in Science, Pharmacy, Pharmaceutical Science, Engineering
- Preferably 8-10 years of relevant working experience in Quality Management System in the pharmaceutical/ biotechnology/ medical device industry
- Knowledge in regulatory requirements
- Knowledge in Quality Management System concepts
- Good communication skills