Vacancy Vacancy Sun, 15 May 2022 17:47:08 +0530 en-us GM-DGM-Production Wed, 31 May 2017 00:00:00 +0530 Job Description :- Candidate should have experience in Pharma Industry Only Ensure that all the functional / operational and safety procedures are adhered during the routine working at R&D to ensure compliance Performing Literature and Patent Search for API and formulation to understand the critical requirements for product development Review and Approval of Standard Operating Procedures to define and harmonize the development process at R&D Cross-functional coordination for the qualification of API and/or excipients for use in the formulations as per regulatory and procedural requirements Development of different types of dosage forms for Regulated Markets like USA, Europe and Canada, preferably Parenteral / Injectable Product Development to enable filing of ANDAs/Dossiers Planning, Support and Execution of lab scale development batches as per GSP/GLP requirements for stability data generation at R&D Planning of various activities and co-ordination with Cross Functional Teams for procurement of API, excipients, equipment/instruments for the developmental activities Product development using Quality by Design (QBD) and Design of Experiments (DOE) approach and exhibit batches completion as per stipulated project timelines Review and approval of various documents like Product Development Report, and other Scientific Reports like Hold Time Study Report, Material Compatibility Study Report, Filter Compatibility Report, Reconstitution Study Report, MMRs, MPRs, Stability Protocols and Reports Coordinating with various departments like Purchase (SCM), Analytical Development, Production, Regulatory Affairs, Quality Assurance etc Scale-up and Technology Transfer of developed products to shop floor for smooth launching of new products Periodic review of the developmental work and guiding the team members in planning and execution of project as per stipulated timelines