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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

Piramal's Discovery Solutions (PDS) site in Ahmedabad, India, provide comprehensive drug discovery services, including synthetic chemistry, in vitro biology, in vitro ADME, in vivo pharmacology, DMPK, bioanalytical services, safety and toxicology, route scouting, and non-GMP scale-up.

Solid organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines

M.Sc / M.Pharm in Life Sciences / Biotechnology / Microbiology / Biochemistry or related field. Axxelent Pharma Science

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.

To prepare and review documents like Risk Assessment protocols for product change over, Cleaning/Process Validation protocols, Master Formula Records, Batch Manufacturing Records. Review technology transfer documents for Mammalian and Microbial products with coordination with R&D, QC and RA.

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.

Knowledge about troubleshooting and experience in handling FETTE & SEJONG compression machines. Required exposure in regulatory audits.