The role ensures accurate development, validation, and execution of analytical testing to support product quality, compliance, and regulatory requirements at the Bonthapally plant.
Responsibilities
Develop new test methods and support required analysis as per line manager and business needs.
Handle method development and validation of finished goods, raw materials, in-process checks (IPC), and API/excipient intermediates using Gas Chromatography(GC), Gas Chromatography-Headspace (GC-HS), High Performance Liquid Chromatography (HPLC) and Ultraviolet Spectroscopy (UV).
Apply analytical techniques, interpret data, support Method Technical Transfer and prepare documents for cosmetic/pharma regulatory filings.
Share analytical results with receiving teams in alignment with project agreements.
Coordinate cross-functional communication and collaborate with R&D, Pilot Plant, Production and Quality Assurance/Quality Control.
Prepare and maintain documentation for internal and external audits (Safety, Quality etc.).
Respond to regulatory deficiency queries related to analytical methods and data.
* Execute routine laboratory activities and identify process gaps as per GLP (Good Laboratory Practices) and ESHA (Environment, Safety, Health & Audit) guidelines.
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