5+

B.Pharma / B.Sc; Trouble Shooter, Granulation, Compression, Coating, Machine Operators and Executives. Primary Packing, Secondary Packing. Hands on experience in HPLC, Chromatography Analyst, Trouble Shooting, and e-LIMS User, LCMS.

Hetero Drugs is an Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs. Heteros business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.

Experience in Regulated Pharma company with knowledge of Manufacturing Process of Tablets, External Preparation and FDA

M.Sc, M. Pharma, B. Pharma. Analytical methods validation, verification and methods transfer. Validation of cleaning methods. Handling HPLC, GC, DR and other instruments. Preparing method validation verification protocol and report. Reviewing analytical hard copy and electronics data.

Environmental monitoring  Media fill visual inspection  Aseptic area monitoring  Handling of media fill activity  Aseptic area personal qualification

As an Associate Regulatory Affairs Director I, you will be a key contributor to regulatory submission strategy, identifying submission risks and opportunities. You will lead regulatory applications and manage procedures through approval.

Seasoned experience in handling of various EU procedure like DCP, MRP, National. National phase handling for EU procedures. Post approval variation compilation and filling to various EU agencies

Knowledge of microbial testing for injectable products and environmental monitoring for sterile manufacturing area. Knowledge of instruments & equipment, method validations, finished dosage and RM testing

Promptly notify and escalate to JAMP headquarters quality department any potential quality or regulatory issues that may affect product quality or regulatory compliance