Executive/Senior Executive - FR&D Injectables / OSD) Cronus Pharma

2.0 - 5.0 years

6 - 7 Lacs

hyderabad

Work from Office

Role & responsibilities Job description Perform protocol for drug excipient compatibility studies and submit the protocol for review and approval Complete lab. experiment hands-on independently (Lab scale to exhibit batch and query handling). Dosage forms experience: Injectables predominantly more than 90% in career. Perform formulation development activities on differentiated formulations and innovative technologies as part of product development. Carry out /Support Scientific literature search (CVM/USFDA/Daily-med/publications). Follow good laboratory practices, good documentation practices (online LNB writing) and maintain the logbooks and forms for equipment/instruments. Compilation, interpretation and review of analytical results and stability data Maintain records of formulations, batch processes, and stability studies. Proficient in drafting, reviewing, and managing technology transfer document (MFR, MPR, stability protocols, justification of specifications etc. as part of TT). Exposure in oral liquids and oral solid dosage forms will have an added advantage Preparation of quality-based product development reports (PDR). Evaluation of alternate vendor Experience in preparing technical and regulatory submissions. Coordinate outsourced activities at the partner site by a regular communication plan. Provide timely technical inputs and timely escalation to ensure successful task completions. Communicate effectively with R&D, production, QA/QC, supply chain teams clients, vendors, and stakeholders regarding project progress and requirements. Qualifications M. Pharm or Ph.D. in Pharmacy with minimum industrial experience of 2 to 5 years in pharmaceutical development and scale-up of products. Support in Technical troubleshooting/ root cause identification/ Investigation/Corrective Action and Preventive Action pertaining to product development or manufacturing activities.

Posted 1 week ago

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