Manage regulatory audits, customer inspections, and internal audits; ensure effective handling of OOS/OOT, deviations, CAPA, and change control activities.
Strong knowledge of country-specific labeling regulations and guidelines across the US, EU, Canada, Australia, and Switzerland, combined with hands-on experience in label development, including CCDS, USPI, and packaging components.
Coordination with quality control department & quality assurance department for getting analytical data with respect to , process optimization batches & validation batches.
M.Sc. in the field of Biology, Molecular Biology, Human Genetics, Cell Biology, Biochemistry, Microbiology. Candidates with UGC-CSIR / NET / GATE / ICMR-JRF / DBT-BET qualifications will be preferred.
Knowledge of global and regional pharmacovigilance regulations. Experience in Pharmacovigilance, data management, and adverse event reporting and processing, with proficiency in relevant software tools.
Facilitate and manage corporate quality audits and regulatory audits and drive the Supplier Qualification Program, including the identification, evaluation through audits, monitoring, maintenance, and re-qualification of vendors.