4-5

Exposure to OSD Manufacturing operations like Granulation, Compression, Coating, Pellet coating. Capsule filling. Expertise in e-BPR and e-log will be added advantage.

Knowledge having batch observations,readings, environmental conditions, labeling, weighing. Inprocess checks and other required observation before,during, after In each compression and Bin feed area, coating and Inspection area., submission of SOPs, BMRs,Records,logs,labels etc., SOP Related Trainings

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.

To supervise and monitor day to day activities of processing and holding of drug product as per define and approved procedures for stability batches and commercial batches.

Contribute to preparation including authoring where relevant and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and, or regional perspective.

Regulatory Affairs professionals with 5 to 8 years of experience in regulatory strategy, dossier review, and submission for the US, EU, and Brazil markets.

Responsible for designing overall marketing and communication strategy of brands. Sales & Market data analysis. Knowledge of product strategy, product launch.

Plan and execute experiments in agreement with quality risk management and GDevP, GMP -Assists in the preparation of and reviews of the technological part of dossier

Experience in Validation Protocol, Report, QMS, Vendor Qualification. Experience in Method Validation