Role & responsibilities

1. Responsible for communication to CFT/ Auditee, keep ready the required documents in coordination with CFT, SME list preparation, opening meeting PPT preparation as per audit scope/ agenda prior to the audit
2. External audits (both Regulatory & Customer audits) and its Compliance activities.
3. Responsible for availability of SMEs & relevant documents during audit, creation of observation and corrective and preventive action (CAPA) arising out of all the external audits (EA) and identification of systemic evaluation of all external audit CAPAs and organizing meeting for assessment and implementation.
4. CAPA response compilation for external audit CAPAs in co-ordination with CFT, timely submission to the respective regulatory authorities/ customers
5. Responsible for identification of CAPA effectiveness check for external audit CAPAs as applicable in coordination with CFT team and its implementation and tracking of closure of the same.
6. Responsible for tracking EA CAPAs for closure,



further updation of respective CAPA response sheet along with completed evidence verification & its compilation.
7. Notify/ escalate overdue EA CAPAs in timely manner to the reporting authority.
8. Cross-functional collaboration for smooth functioning of EA life cycle
9. Registration and review of product complaints & recall and to involve in Mock Recall across Biologics division sites and responsible for SOP compliance
10. Impact evaluation, initiation/ review of Change Controls and Deviations pertaining to Complaints, Recalls. of across Biologics sites of Biologics division
11. Responsible to prepare training module & track the action items as per respective customer quality agreements.
12. Follow safety practices implemented across site and ensure adherence

Preferred candidate profile Responsible for External Audits (Regulatory & Customer), Product Complaints & Recalls Quality Agreements, Stake-holder communications, Compliance with regulations & CGMP requirements related to Shameerpet site.

📌 QA - Audit & Compliance (Hyderabad)
🏢 Biological E
📍 Hyderabad