Company Jobs

IPQA Mfg. & Packing, Shop floor activities, Review of equipment audit trails / BMR, BPR review / line clearance.

Exciting opportunity for candidates who are interested to pursue their career as Executive - Clinical Research in Nutraceutical Industry.

Method development & validation for tablets, capsules, creams & ointments. Exposure to US/EU regulatory requirements.

B.Sc./ M.Sc./ B.Pharm / M.Pharm. Manufacturing / Packing, Quality Control, Quality Assurance. Exposure to OSD Manufacturing operations like Granulation, Compression, Coating, Pellet coating, Capsule filling, Primary Packing and Secondary Packing. Working in USFDA Plant.

M.Sc/ B.Pharm / M.Pharm. To plan, prepare and review of high quality dossier with support and guidance, assuring technical concurrency and regulatory compliance, meeting agreed upon timeline.

Works in close collaboration with the external service provider and Investigators to ensure quality and quantity commitments are achieved in a timely and efficient manner.

Managing initial clinical trial application submissions in the EU according to the Clinical Trial Regulation and all changes during the life cycle of clinical trials.

Preparing eCRF specifications, Edit check specification and other study specific set up documents.

Regulatory Coordinator will support the Director, Regulatory Affairs and other Senior Directors in International Markets to organize and perform required tasks for regulatory affairs in order to maintain compliance with current regulations and in-house standards.