Key responsibility Areas :
Scouting new products from various TPMs based on organization needs
Site and product screening in terms of QA and Regulatory compliance, negotiating on transfer price for the product, QA audit for the site, follow up for CAPA& red alert identification. Working on additional investment proposals with TPMs.
Support TPM for product manufacturing license, procuring product license and complete technical dossier from TPM for QA/Regulatory/Medical and technical operation review and gap analysis.
Follow up with cross functional team for gap analysis, product dossier compliance from TPMs, site and product approval certification. Support to close product supply agreement and quality agreement
Accountable for tracking all the development activities on a project management basis with crossfunctional working across QA, medical, regulatory, Tech ops, distribution, SAP & purchase teams. Project managing end to end allocated divisions for new product initiatives with internal process alignment.
Qualification : degree in Pharmacy from reputed Institute with MBA
Work Experience : 10 -15 years of relevant experience in overall pharmaceutical formulation operations, 3-4 years in project management