Senior Officer - QA (Investigation)

Glenmark Life Sciences

3 - 7 years

4 - 9 Lacs

ankleshwar

Posted:None| Platform:

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Skills Required

investigation change control oos oot deviation

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

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