Job Description

Job description Asst Manager : Quality Assurance - Audit & Compliance Experience: 8 to 11 yrs Job responsibilities: Performed QA audits in compliance with established study protocols/SOPs/System. Preparation and review trending of compliance systems for Quality Matrix Review. Conducted evaluations to ensure site as per established standards. Involved in self-inspection in Injection. Ensured that audit results are formally recorded and reported and that corrective actions (CAPA) are documented. Trained the staff with GLP, GMS,current 483, review 483, identify the gap in system and implementation, role of QA, regulatory audits, etc. Ensured to adhere to Good Laboratory Practice (GCP) regulations and guidelines, and current GMP requirements. Review of risk assessment against current guide,system,SOP. Responsible for overall supervision of compliance group, compliance activities and databases. Escalate compliance concern to senior management in a timely manner. Review and approve pre and post implementation major change controls. Review of CAPA for deviation, OOS, EM and regulatory audits, draft procedures, evaluate change. Follow-up on CAPA completion for deviation, OOS, EM and audits for completion. Oversee implementation of Trackwise projects. Looking for interested professionals matching the requirement and eager to join our organization.