Hyderabad

Candidates experience in Sterile Quality Assurance, covering QMS, Validation, IPQA, and related areas.

Personnel handling this profile will be responsible for performing reactions as per the requirement of the project. They are also responsible for documenting the observations in relevant note books.

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.

Masters, Integrated Masters Degree in Natural or Agricultural or Pharmaceutical Sciences from a recognized University OR Bachelors degree in Engineering or Technology or Medicine from a recognized University

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.

To participate in sample processing for PK, ADME assays and handling of LCMS/MS. Ability to adapt to the dynamic team environment. Processing of different matrices samples of PK studies. Optimization of test compounds manually as well as automated on LCMS/MS. M.Pharm in Pharmaceutical sciences, Pharmaceutical Analysis who has interest and passion for LC/MS related bioanalysis

Post-graduate degree including integrated PG degree such as M.S Pharm, M. Pharm, M.Sc, M. Tech or Equivalent with specialization in Biotechnology, Life Sciences, Pharmacology and Toxicology.

Must have hands on experience in working with chemical methods and handling instruments like Prep HPLC and HPLC. Expertise in HPLC & Prep HPLC method development and basic undersatnding in data interpretation of various analytical technique such as LCMS, GCMS, FTIR, UV-Visible, NMR etc is required.