Urgent requirement at Oracity Life Sciences
Assistant Manager – QA – 02 Location – Butibori – Nagpur
Total Experience – More than 6 Yrs
1) Handling of Validation (Process and Cleaning), Evaluation of Change control w.r.t. QA, Regulatory prospective and its timely Closure, Site shift activities,
Approval of Master documents Like BMR/BPR/ Qualification/ SOPS etc. and control of documentation includes Issuance, tracking and reconciliation of BMR/ BPR/Quality records etc.
2) Review of Dossier for submission to various regulatory agencies like FDA, WHO, USFDA, Customers and active participation in Queries and complete response from agencies.
3) Responsible for Audit, Response and Compliance of observations of Regulatory and customer audits at site. 4) Responsible for Quality Management System (QMS) activity which includes Deviations, Market complaints, Out of specification, Investigations, Quality Audits, Review and approval of APRs etc.
5) Involvement in critical/major Quality decision with senior management.
6) Handling and control of Shopfloor activities (IPQA).
Kindly share resume on neha.singh@oracitylifesciences