5+

Preparation of original DMF, amendments, Annual reports and Review of adequacy of documents for submission. Compilation, review and submission of various Drug master files for US, EU, TGA, Canada and other markets as per respective regulatory guidelines and checklist

B.Pharm, M.Pharm, B.E, B. Tech with 6 to 10 years of experience in Supervising and Controlling Production areas like Aseptic Filling, Vial Washing, Autoclave, Lyophilizer, Visual Inspection and Packing. Should have knowledge of QMS activities

Prepares, literature review, abstracts, posters, and slide sets, and Manuscripts sophisticated working from various data sources including clinical study reports, patient profiles, protocols etc.

Walk-in Interview for Production Operator, QC Analyst, Engineering Operator, Fix Term Employee

Expertise of Finish goods testing. Stability, RM Analytical Method Validation, Dissolution, HPLC, PMQC and knowledge of handle other sophisticated instruments like GC, XRD, ICPMS, LCMS.

Responsible for process validation and cleaning validations and respective documentation. Responsible for Equipment and utilities qualification and periodic validation.

Experience in IPQA, QMS, validation, documentation, aerosol manufacturing, filling machine, sterile manufacturing.

Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.

Masters degree in Pharmacy or Pharmaceutical Chemistry or Pharmacology or Chemistry or Biochemistry or Bacteriology or Medicine or Microbiology or Biotechnology; in the Regional Drugs Testing Laboratory, Guwahati, CDSCO, DGHS, Ministry of Health and Family Welfare.