Company Jobs

Having exposure related Environment Monitoring in formulation, water analysis, various Microbiological test like sterility, BET, MLT etc. Having exposure related to regulatory plant and basic know of GLP GMP. Ready to work in rotational shift.

Production QMS Quality Management System Handling of QMS activities like Deviation, Incident, Investigation, CCP, Protocol Preparation, Risk Assessment etc.

Should have experience on HPLC (Agilent) Analysis & Wet Chemistry Analysis. HPLC Agilent - Trouble Shooting, Analysis & CGLP Knowledge.

Responsible for Execution of Placebo, Scale up & Trial batches. Review Validation protocol, Report, responsible for validation batches manufacturing. Preparation of scale up and trial batch summary to support the commercialization of products.

A Masters M.Pharm or M.Sc. or M.Tech. or M.E. or Bachelors B.Tech or B.E. or B.Pharm. An understanding of the Process Development and Industrial perspective of Biotherapeutics/ Biosimilars. Basic understanding of analytical techniques, statistical analysis, data management and analysis.

Experiences in HPLC, GC, LCMS, GCMS, IR, UV, Dissolution, Polarimeter, Potentiometric titrations, KF, PSD by Malvern and Other wet & Physical analysis

Preparation of Clinical Study Reports CSR for EMEA, WHO, SAHPRA. TGA, US- FDA, Costa Rica, others regulatory and Appendices and formats as per projects

M.Sc, M.Tech, M.Pharm with prior experience in Quality Assurance with 5-10 years in GMP pharmaceutical organization.

Exposure of Waters HPLC, Dissolution, GC and other Instruments with AMV, RM, PM, FP product analysis Handling of QMS related Activities Exposure of various instruments/ software like Empower 3, LIMS and other softwares