Team Leader - MS&T (Alternate Vendor Development)

Alembic Pharmaceuticals Ltd is looking for Team Leader - MS&T (Alternate Vendor Development) role based at Alembic Research Centre, Vadodara.

Role & responsibilities

• Evaluation of Alternative source of Active Pharmaceutical Ingredient (API) & Excipient based on the regulatory requirement.
• Evaluation of vendor documents & coordination with vendor for establishing equivalency as per IH requirement.
• Document preparation for application of various licenses.
• Independently handling of Lab scale feasibility trials & stability studies.
• Documentation - Preparation and review of documents like Lab scale feasibility Trial Report, Stability studies report, MFC, PVP, PVR, additional testing protocol, cleaning validation, Stability protocol, Hold time study protocol, Raw material specifications, Product specifications etc. as per regulatory requirements.
• Coordination with regulatory & arrangement of required documents for approval of proposed changes.
• Well verse with SAP for creation of Raw material codes, Semi-Finished Product Codes & BOM update.
• Effective Handling of Change Control for documents revision & Vendor qualification.
• Coordinate with cross-functional departments like Purchase, ADL, PDC, QA, PPIC, BD and RA for readiness of technology transfer documents & timely execution of batches.
• Effective handling of trouble shooting products & implementing of corrective action as per regulatory requirement.

Perks and benefits

Best In Industry

If you are interested for this role, please share your updated resume to shivani.zala@alembic.co.in with position title "AVD"