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
Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx. Rs. 830 Crores. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.
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.
Establishment of procedures to ensure adherence to trial protocols and administrative requirements. Ensuring the timely recruitment of trial participants with secure randomization processes and subsequent efficient and effective data management.