Job Summary

Responsible for reviewing of all analytical data generated in ARD-Test Centre in compliance with cGMP and related SOPs and preparing reports for submission to the Regulatory agencies.

Primarily responsible for creating and revising all analytical test methods (chemical and physical) and specifications generated in Analytical R&D; as per current Apotex format and posting the methods on Apoweb. Responsible for the completion of R&D; Change Control Requests (CCRs) in Trackwise for method creation to transfer of methods to the commercial site. Responsible for support and completion of R&D; CCRs in Trackwise for generation and update of specifications. Also responsible for creating, updating and maintanance of Apotex technical report templates.

This person is seen as a leader and acts as a backup-supervisor for all project updates or queries on submission documents.

Job Responsibilities
- Requests product codes for current projects from Consultant, Financial data Processes (for SAP product codes) or from Supervisor, NPL-Master Prod&Pkg; Docs (for product acronyms)



and assigns new method numbers for Analytical R&D; and ARPL, as applicable, using Excel database.
- Creates and revises analytical test methods generated in Analytical R&D; using current method templates, for example: chromatographic methods, physico-chemical test methods, dissolution test methods.
- Assists PD-SD chemists, Chemistry & Compendia associates, and ARD scientific leaders with CCR creation and reviews all associated documents prior to management approval.
- Initiates and supports change controls as relevant to R&D; specifications.
- Liaises with Analytical R&D;, Commercial labs, QC Documentation group, RA and R&D; QA for CCR s signatures and impact analysis.
- Checks the method files into Content Server and creates workflow in Workflow Manager.
- Posts all analytical methods on Apoweb (Analytical Test methods site), maintains the site archive, and adds all new product/excipient names to the Apowe

📌 Senior Executive (Bengaluru)
🏢 Apotex
📍 Bengaluru