Company Jobs

Must have experience in calibration of instruments like Balances, pH, KF and potentiometry etc. Must have experience in handling LIMS and Caliber LIMS software applications.

Candidate who should have good knowledge in secondary packing area, track and trace, QMS activity. Require good knowledge in Complex Skid, NDDS, Lyo, Batch Manufacturing, Aseptic PFS, Vials Liquid, Autoclave, TS.

2-6 YEARS OF EXPERIENCE IN FINISHED GOODS, RAW MATERIAL and STABILITY. 2-5 YEARS OF EXPERIENCE IN MANUFACTURING GRANULATION, COMPRESSION and COATING and PACKING AREA

Oversees the development, implementation, and maintenance of the Quality Management System within the Probiotics or Non-Aseptic manufacturing facility. This includes ensuring that all processes, procedures, and documentation comply with relevant regulatory standards such as Good Manufacturing Practices.

Regulatory Submissions Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations, while ensuring compliance with relevant guidelines and regulations. API Equipment Handling.

Knowledge of Documentation, QMS, Deviation, Change Control, Market Complaint, OOS, OOT, Validation Qualification, IPQA, Audit Compliance.

Pre formulation studies of Pharmaceutical & Medicinal Devices and to check the compatibility of the API with different excipients. Formulation development of Pharmaceutical & Medicinal Devices. Execution of successful technology transfer at commercial site.

This is a hands-on, non-supervisory, non-laboratory role in the India Biologics department. The incumbent will support the reference standard program within the Global Biologics department. The incumbent in this role will focus on supporting the suitability program, including preparing and reviewing CSU testing protocols, providing technical assistance to testing labs, reviewing analytical data and preparing summary reports to assist in confirming the continued suitability of USP Reference Standards.