KEY DUTIES AND RESPONSIBILITES:
· Responsible for all production and related compliance documentation
· Conduct deviation investigation on batch non-conformabilities and manufacturing failures
· Write detail technical investigation reports with thorough root cause analysis and robust CAPA.
· Implement checks to ensure CAPA effectiveness
· To identify and correct all forms of potential recurring quality issue.
· Work with Quality team on investigation of all market customer complaints
· Communicate and train manufacturing teams to eliminate deviations caused by human errors
· Close engagement with shopfloor technicians to understand daily manufacturing progress and issues.
EDUCATION & EXPERIENCE
· Education Level – Degree holder in Pharmacy, life science or Engineering
· Minimum 3 years relevant experience with pharmaceutical companies. Preferably in a Quality function and a Singapore registered Pharmacist.
· Strong GMP experience: Having already participated and managed audits of external agencies (USFDA, MHRA etc)
· People management: leadership, cooperative, ability to influence
· Excellent critical thinking and problem solving capabilities
· Teamwork, influencing, communication skills, negotiation, conflict management
· Effective problem analysis and problem-solving
