Manage regulatory audits, customer inspections, and internal audits; ensure effective handling of OOS/OOT, deviations, CAPA, and change control activities.
The candidate must be a continuing student in undergraduate/ postgraduate engineering or undergraduate/ postgraduate science program in any branch of Biological Science. Recently completed students who are not enrolled in any job, may also apply.
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.
Knowledge of global and regional pharmacovigilance regulations. Experience in Pharmacovigilance, data management, and adverse event reporting and processing, with proficiency in relevant software tools.
Ph.D / MD / MS / MDS or equivalent degree OR three years of research, teaching, design and development after MVSc / M.Pharm / M.E / M.Tech with at least one research paper in Science Citation Index Journal.
Visit the customers as per the generated database and understand the current infrastructure, specified and potential needs. Analysing customer feedback data to determine whether customers are satisfied with company products and services.
Monitoring of Terminal sterilization, filling, Lyophilizer operation, Glove integrity etc. Should be able to do the reconciliation and revie of BMR. Candidate should be able to handle media fill.
M.Sc. in any life science stream. Knowledge of Cell culture and Molecular biology. Evaluating deubiquitinases as the newer mode of rescue of hyperlipidemia laden pancreatic beta-cells. Manipal Academy of Higher Education