Team Lead MSAT- Injectable

R&D Interface

  • Interface between R&D and manufacturing plant
  • Reviewing of new products status at R&D, Support R&D and plant teams to make facility ready for the execution of optimization and Trial/exhibit batches.
  • New products transfer to in-house sterile manufacturing sites.
  • Accountable for new product Launch products at sterile manufacturing sites especially.
  • Facility identification for China, Russia executions, Technical assessments, gap analysis.
  • Technology transfer to china. Russia sites.
  • End to end responsibility of new products from New Product to Exhibit execution

Technology Transfer (Sterile Drug Products)

  • Define the framework & guidelines for Tech Transfer process & procedures
  • Regularly review the process to ensure continuous improvements
  • Prioritize Tech Transfer programmes and allocate resources to ensure timely completion of the Tech Transfer projects
  • Review the site evaluation and project plan prepared by the team, give recommendations for changes required; Manage all interface across functions like, Production, Process Eng., Quality, and Regulatory; In order to ensure successful tech transfer.

Documentation

  • Review and Approval of Technical protocols, Reports and Product impact assessments related to new product executions in process validations.
  • Support for regulatory filings and compliance issues for sterile injectable products.
  • Support for regulatory audits.

Process Validation and Compilation

  • Monitoring/Technical assessment and support for scale up, manufacturing of Process validation batches for site to site transfer of injectable product and new products from R&D.
  • Technical support for troubleshooting, root cause analysis, and product impact assessments for non-conformance (Incidents, OOS, OOT & Regulatory queries) investigations and process changes/improvements.
  • Review and Approval of change controls, Incidents and risk assessment with respect to Validation and qualification activities.
  • Co-ordination with CFTs (i.e. Production, QA, QC) for exhibit batches, process validation, BMR activity and various documentation.
  • Review and Approve of PPQP & PVRs.


Education & Experience

M Pharm/ M.Tech with 12 to15 years of experience in Technology Transfer, End-to-end product development and troubleshooting,

Posted
07/14/2022
Location
visakhapatnam, AP, IN