Company Jobs

Granulation, Coating, Compression, Bottle Packing Machine Exposure, RMG, FBE, FETTE, Autocoaters /Bottle Packing line with track and trace system. 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.

Looking to hire Head Of Regulatory Affairs - an aggressive, dynamic Regulatory Affairs Professional. Who would assume the Regulatory strategic, filing and post approval life cycle management and Quality, Technical and regulatory compliance responsibilities as per EU, UK, USA, and PIC, s requirements.

Experience in API Production, Bulk Drug, API Production To be responsible for Batch start up activity, monitoring, calibration of balance and other instruction given by the Superior, Should have exposure in reactors, centrifuges, and a clean room equipped with sound knowledge in cGMP and SOPs.

Expertise in Injectables, Biosimilars as primary requirement and experience in handling Oral dosage forms as additional requirement. Support business decision makers in terms of resource allocation, risk management, collaboration, and prioritization. Operational technical support to ensure product reliability, support portfolio growth, cost improvement by optimize.

proven work experience in Regulatory Affairs in the Pharmaceutical or Healthcare, or organizations in other regulated sectors. The incumbent is also responsible for acting in compliance with country policies and practices to reduce Takeda exposure to regulatory risks as well as for developing the local Regulatory team as appropriate.

Ph.D. in Chemistry or a related field. Adhere strictly to cGMP norms and factory safety rules. Independently execute organic reactions in the lab, generate new ideas, and demonstrate strong literature research skills.

Lead scientific engagement with their Medical Experts. Implement clinical and educational strategies and respond to unsolicited medical enquiries. Engage with Medical Experts to educate on medical/ scientific information

The individual has experience in handling various analytical techniques such as such as HPLC, GC, CE-SDS, SEC, ELISA, qPCR, DSC, Bioassay, Karl Fischer, UV, LC-MS, Dissolution, Disintegration, X-ray diffraction, etc.

To review and assess data based on Analytical QBD based approach. To ensure analytical development data supports to robust test method and suitable to entire product lifecycle.