Assistant Manager - Compliance (Site Investigation Team

Position Purpose:

Responsible for managing and supporting site investigations related to deviations, OOS (Out of Specification), OOT (Out of Trend), microbial excursions, and manufacturing non-conformances within a GMP-regulated environment.

Key Responsibility:

1. Lead and support investigations for deviations, OOS, OOT, and market complaints using structured root cause analysis methodologies.
2. Conduct microbial investigations, impact assessments, and CAPA implementation to ensure regulatory compliance and prevent recurrence.
3. Collaborate with cross-functional teams to drive timely closure of quality events and achieve effective investigation outcomes.
4. Review investigation reports, assess data integrity, and ensure compliance with GMP, GDP, and ALCOA principles.
5. Perform trend analysis of quality events and provide recommendations for continuous improvement.
6. Support internal and external audits, including audit responses and compliance readiness activities.
7. Manage investigation tracking, documentation control, and QMS activities through TrackWise and other quality systems.
8. Coordinate department training programs, SAP SuccessFactors learning management activities, and employee qualification compliance.
9. Act as a reviewer and technical resource for investigation strategies, risk assessments, and quality decision-making processes.

Education Qualifications:

1. Minimum Bachelor's Degree in Biotechnology, Chemical Engineering, or any Engineering-related field.