ResponsibilitiesEnsure compliance of global ICSR distribution by correct distribution rule set-up in the Safety Database. This includes : Regular monitoring of regulatory information system.Regular review of distribution requirements received from ASRsPerform plausibility checks and impact analysis of changes in regulations and ensure implementation of distribution rules in Safety DatabaseContact person for ASRs for redistribution of cases, updates of distribution rules, contacts, products, timelines and local requirements in the Safety databaseContact person for ICSR reporting requirements for other GPV groups, e.g. Case Processing, QPPV, Compliance, Safety Database OperationsAct as deputy ICSR Distribution CoordinatorPerform regulatory reporting to EMAMonitor Global Safety database Submission section for received/failed acknowledgementsQualification & ExperienceMaster in Science, Ph.D. in Life Sciences, B.E. or B.Tech or equivalent Excellent

Responsibilities Lead end-to-end technology transfer of formulations (OSD / semi-solids as applicable).  Plan, review, and approve Technology Transfer Protocols (TTP), Reports (TTR), and risk assessments.  Coordinate transfers from R&D, pilot plant, contract manufacturers, or global sites.  Ensure readiness of manufacturing processes, equipment, and documentation. Process Scale-Up & Validation  Lead scale-up, exhibit, and PPQ batches.  Define and monitor CPPs, CQAs, and control strategies.  Support and review process validation, cleaning validation, and hold time studies.  Drive process optimization and yield improvement initiatives. Cross-Functional Coordination  Act as a technical interface between R&D, Production, QA, QC, Engineering, Supply Chain, and Regulatory Affairs.  Provide technical inputs for regulatory filings, queries, and variations.  Support new product introduction (NPI) and site transfer projects.Qualification & ExperienceEducation: B. Pharm / M. Pharm

ResponsibilitiesIn this role you are required to solve routine problems, largely through precedent and referral to general guidelines  Your expected interactions are within your own team and direct supervisor  You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments  The decisions that you make would impact your own work  You will be an individual contributor as a part of a team, with a predetermined, focused scope of work  Please note that this role may require you to work in rotational shifts, Bachelor of Pharmacy,Master of PharmacyQualification & ExperienceQualifications:Bachelor of Pharmacy/Master of Pharmacy Years of Experience:1 to 3 years

ResponsibilitiesIn this role you are required to do analysis and solving of lower-complexity problems  Your day to day interaction is with peers within Accenture before updating supervisors  In this role you may have limited exposure with clients and/or Accenture management  You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments  The decisions you make impact your own work and may impact the work of others  You will be an individual contributor as a part of a team, with a focused scope of work  Please note that this role may require you to work in rotational shifts In this role you are required to do analysis and solving of lower-complexity problems  Your day to day interaction is with peers within Accenture before updating supervisors  In this role you may have limited exposure with clients and/or Accenture management  You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments  The decisions you make impact your own work and may impact the work of others  You will be an individual contributor as a part of a team, with a focused scope of work  Please note that this role may require you to work in rotational shifts Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems  Your day to day interaction is with peers within Accenture before updating supervisors  In this role you may have limited exposure with clients and/or Accenture management  You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments  The decisions you make impact your own work and may impact the work of others  You will be an individual contributor as a part of a team, with a focused scope of work  Please note that this role may require you to work in rotational shiftsQualification & ExperienceQualifications:Bachelor of Pharmacy/Master of Pharmacy Years of Experience:3 to 5 years

Responsibilities Finish product and stability sample Analysis and Documentation as per GDP. Analysis and Documentation of Bulk Sample. Analysis and Documentations of In process Samples and Daily Water Analysis.  Analysis of cream, Ointment , Topical solutions & MDI & DPI products

ResponsibilitiesSampling, Testing, Release and rejection of Raw material. Handling of LIMS Software. Handling of UV Vis Spectrophotometer (Shimadzu 1800 & 1900 Lab Solution). Handling of Digital Microscope. Handling of Polarimeter. Handling of Coulometer titration. Handling of Karl Fisher titration. Handling of TLC Visualizer

ResponsibilitiesLiterature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products towards different regulatory submission. Review of BA/BE study protocol and provide Pharmacokinetic (PK) inputs into the study protocols  Coordinate with the CRO for finalizing pilot and pivotal biostudy protocol for DCGI BE application. Develop protocol for patient based BA/BE studies & PD end point study for complex generics. Perform PK and Statistical analysis of in-vivo data obtained from BA/BE and pharmacokinetics studies using Phoenix Software. Use modeling & simulation tools for study optimization. Respond to regulatory queries related to PK analysis and study interpretation.Qualification & ExperienceGraduate : M.Pharm /Pharm D Experience Tenure : Minimum 3 years of relevant experience