Review of approved vendor list in-line with submitted, current DMF. Review of Raw materials, Packing materials specification and analytical procedures. Preparation of ODMF, Technical package as per customer requirement.
Review of BPR, batch cleaning record, test data sheet, Sampling of API finished goods. Preparation of APQR. Handing of QMS document Change control, Deviation, CAPA, OOS, OOT review.
To design and implement integrated strategies, linking appropriate chromatography and mass spectrometry tools, to perform a qualitative and quantitative assessment of product related variants and impurities.
Having experience in Injectable, Review of Calibrations, Preventive maintenance programmes. Review of utility systems and process equipment data. Review of alarms, Audit trails, drawings, investigations and Handling of Break downs.
Hetero Drugs is an Indian pharmaceutical company and the worlds largest producer of anti-retroviral drugs. Heteros business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.
Intas is one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies in the world. Today, Intas is present in more than 85 countries worldwide and is growing at 20% CAGR. Around 70% of its revenues come from the international markets, particularly the highly regulated markets of EU and US. At Intas, every day and everyone works to create a world of good health, happiness and hope.
M.Pharm with 15 to 20 years of experience in Formulation development of sterile, non-sterile Dosage forms as per guidelines of US, EU, Canada, Brazil and ROW market. Literature search, Pre - formulation and compatibility studies,formulation & development as per QbD, Scale-up and Technology transfer.