• Ensure proper guidance on quality issues to the product development teams.• Review the document received from R&D, ADL etc., so that the same can be shared with authorities and customers.• Review the process changes proposals and help the team members provides guidance on change proposals.• Review the in house expert reports quality overall summary (QOS) prepared by the team members.• Ensure proper stage gate compliance at various stages of product development.• Ensure that internal audits are conduct properly.• Review the developmental report and other document.• Ensure appropriates qualification of CRO.• Ensure appropriates qualification of external manufacturing sites.• Ensure self inspection programs are conducted properly across IPDO• Review the existing GMPs, STPs, GLPs, or SOPs and update them if required.• Help the team members manages change controls, deviation, incidents.• Ensure internation customers audits, regulatory audits etc. is handled in a suitable manner.• Ensure proper maintenance of central documentation i.e the development quality assurance (DQA) document cell.• Audit Analytical Method Development Reports, Method Validation Protocols/Reports etc and to provide support to Regulatory Filing for all markets• Support audits/quality investigation issues of other business unit.• Ensure thorough inspection of quality till the exhibit batch stage.• Ensure quality by design, i.e. ensure robustness of product and process• Preparation of various document of R&D like PDR, PTD, Scale up Protocol/Reports etc.• Help the Regulatory Affairs & R&D Department for Response to DMF Deficiencies (QPO).• Coordinate with other departments (i.e QC/QA/Production, R&D, ADL, RA, IPR, Engg.)

Process development, literature search, development of patent non-infringing reaction, research proposal, cost management, API/ intermediates synthesis, impurity synthesis, synthesis of various multi step drugs, purification, data interpretation, lab development report, process package, DMF, technology transfer, scale up of reaction to bulk scale

Project work of API (R&D) like process development, literature search, patent search, reaction design, research proposal, cost management, API/ intermediates synthesis, impurity synthesis, synthesis of various multi step drugs, purification, data interpretation, lab development report, process package, DMF, technology transfer, scale up of reaction to pilot scale