Sr. Officer - QALL

Glenmark Pharmaceuticals

0 years

0 Lacs

india

Posted:1 day ago| Platform: Foundit logo

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Skills Required

qms compliance glp compliance process validation batch manufacturing record technology transfer coa product data review batch packing record finished product specifications

Work Mode

On-site

Job Type

Full Time

Job Description

Work Location - Baddi, Baroda & Navsari

Ensure GMP/GLP compliance at Contract Manufacturing sites and third party sites and provide registration documents and required support for registration from site.

Ensure availability of current valid master documents like raw material /packing material /finished product specifications batch manufacturing record /batch packing record at site and retrieval of obsolete documents.
To check and find non compliances at Contract Manufacturing /Third Party location and ensure corrective and preventive action.
To execute, ensure and monitor process validation / Technology Transfer activities, Unit Operation, QMS Compliance at site and arrange for the reports.
Preparation and submission of annual product review report for Contract Manufacturing products manufactured at site.
Visit at Third party manufacturing sites for product data review and COA.
Co-ordinate with PPIC, Nasik QA office and PDC for routine activities and queries.
Verification of RM/PM testing as per GPL specification & Sampling Plan at Contract Manufacturing /Third Party Site and approval of site master documents, Training to be given for shop floor persons related to change implementation in BMR, BPR to execute the quality product & GMP process at LL/ TP site

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