Executive Quality Assurance IPQA

Sun Pharma

5 - 7 years

6 - 7 Lacs

bengaluru

Posted:1 day ago| Platform:

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Skills Required

process of biological products guidance for industry basics of biotechnology who and their requirements in raw material ich intermediates & finished products. gxp computer generated data audit trail primary packing material retrieval inventory management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Overseeing day to day activities of Bulk Manufacturing area and ensuring the cGMP compliance.
Preparation & Review of SOPs pertinent to QA SOPs Through EDMS
To Handle Out of Specification (OOS), Deviation, Out of Trend (OOT), Laboratory Event, Change Control, Corrective Action and Preventive Action (CAPA) with assurance of appropriate Action Plan Through Track Wise System.
To ensure GMP compliance to approved procedures / practices as per SOP.
Compliance verification in Bulk Manufacturing, Ware house, HR/Admin, Engineering, QC by visits.
Review of Protocol & Reports w.r.t Validation. Stability Study, Hold times Studies.
Control and reconciliation of Master / Working Cell Banks and maintenance of relevant documentation.
Review of BPR & Batch release, Analytical data Review and Closure.
Handling of Coordinator role for EDMS (Electronic Document Management System).
Handling of BRMS (Batch Records Management) application with the QA Approver and QA request Approver.
Preparation of APQR.
Handling of SAP HANA for material Management and Quality Management.
To assess housekeeping activities in all the general areas/GMP associated area in coordination with Admin supervisor/Manager.
Arraigning trainings to all GMP departments w.r.t SOPs/Protocols.
Issuance, Control & Archival of documents.

Preferred candidate profile

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