5+

Handling and Execution and investigation of QMS documents in change controls, deviations, and CAPA. Review of Analytical Method Validations, Method Transfers, Protocols & Reports. Experience in review of HPLC, GC, LCMS calibration data & Analytical Data review. 

Review of various formulation and packing development, technology transfer documents like but not limited to Master Formula, Master Formula Card, Product Development Report, Dissolution Development report, Elemental Impurity Risk Assessment Report, Stability plan, QbD based Risk Assessment report, Failure Mode Effect Analysis, Process Validation Protocol

Use technical knowledge to perform in-depth review of API drug master file as per current US FDA expectations; identify deficiencies and formulate strategies to resolve them. Close coordination with Packaging material and Excipient vendors, placing orders, arranging technical documents to Analytical and Regulatory teams.

Ensures that direct reports have development and training plans, according to IDP process. Coaches the direct reports on a regular basis, and plans, organizes coaching with external providers if needed.

Finished, Stability Section, knowledge of Instrument - HPLC, GC. Preferably know-how of Chromeleon Software.

Responsible to handle the team to achieve the set targets & maintain qualitative, quantitative as well as cGMP aspects.

Perform complex scientific study data review and management of CDM, Study Responsible Scientist SRS, and Study Responsible Physician related queries in EDC system. Involvement in other clinical data review activities e.g., Coding, SAE reconciliation is possible.

Review all activities promoted or induced by Bayer Mumbai CH Division that directly or indirectly involve exposure of a human being to any pharmaceutical & OTC products. Make sure that all promotional activities are made in accordance with local Regulations.

After a journey of growth spanning 27 years as Cadila Healthcare Ltd. and the Zydus Group, we have evolved and transformed ourselves in response to the changing times.