
Senior Officer
8 hours ago
Role & responsibilities
- To carry out Investigation of Incident, OOS (Out of specification), OOT (Out of trend) and Market complaint with the help of concerned departments.
- Review /generate control number of Incident/CAPA /OOS/OOT & Market complaint.
- To prepare and review of Quarterly and Annual trend of incident, OOS, OOT, Market complaint and CAPA.
- To review raw data and supporting documents for Incident, OOS, OOT, Market complaint and CAPA.
- Responsible for follow up and implementation of CAPA (Corrective and preventive action).
- Communication with production, Quality control, Warehouse, Engineering, HR and SHE for closing of OOS, OOT, Incident, Market complaint and CAPA.
- To prepare supporting document for APQR and monthly report.
- To perform the required transactions in SAP.
- To maintain archival of OOS and OOT Investigation documents.
- To perform activity allotted by Manager/Head QA.
- To initiate change control related to Incident, OOS (Out of specification) and OOT (Out of trend).
- To prepare Limit of OOT (Out of trend) as per SOP.
Preferred candidate profile
Form API Industry
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