Develop, maintain, and update laboratory systems and documentation, including SOPs, IQ/OQ/PQ documents, training records, and related quality documents.
Granules India is a vertically integrated, high-growth pharmaceutical company with 38 years of proven performance and increasing performance and increasing presence across the world.
Review QMS documents, SOPs, processes and records for compliance with GMP requirements; Support OOS, OOT, deviations, change controls, CAPA, risk assessments and investigations; Ensure compliance with ALCOA+ data integrity principles
Solid organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
To co-ordinate with Cross Functional Team for getting various documents required for filing the product in India. Responsible for reviewing CMC documents to be submitted in dossier as per regulatory guidelines.
Assist in day-to-day production activities as per SOPs. Conduct basic chemical handling, mixing, and batch processing.
Monitor production processes and record process parameters.
Hands-on experience in XRD, DSC, TGA, Microscopy, Zetasizer and PSA; Responsible for day-to-day laboratory activities and team leadership; Experience in GMP-compliant laboratories and QMS.