Work both independently and as part of intra, inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards.
Regular reporting in Envision. To maintain the desired call average per month and frequency of calls to be done as expected with respect to Dual Ranking of Customers. Call objectives should be managed to give focus on various Products as agreed.
Support DM Delivery Leads to maintain CDM specified systems and types of deliverables, milestone achievements, risks and mitigations and data transfer agreements, and other study administrative needs.
Having Experience in Environmental Monitoring, Water Testing, In process Sampling, Analysis of Bulk Water, Finished and API by MLT, Bioburden, BET, Sterility, PET and Antibiotic Assay.
B.Pharm / M.Pharm; To perform equipment qualification, utility qualification activity with proper documentations. To perform Computer system validation. To investigate deviation, change request, OOS, market complaint etc.
Create and review regulatory documentation for Drug, Device and Combination product renewals and other life cycle maintenance-related submissions. Track status and progress of regulatory documentation.
Lab Exposure, Analytical Method Validation. Review of Specification. Method of Analysis Protocol Handing of 00S and 00T. Investigation and Lab event. Review & Approval of QC Documents. Knowledge of Qualification and Validation related Activities. Audit Trail Review etc
Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement. Demonstrated computer literacy, particularly in the use and management of relational databases.
Execute the Formulation Technology Transfer activities across all Cipla sites and CMO to standardize, strengthen and improve the technology transfer processes and systems in line with regulations