Job Title
Lead MSTG Orals
Job Grade
G6
Function
MSTG
Sub-function
MSTG-Orals
Manager's Job Title
Senior Vice President
Skip Level Manager's Title
Function Head Title:
Senior Vice President
Location:
Halol
No. of Direct Reports (if any)
5
Date Of Joining
Job Summary
Lead MSTG Orals
Areas of Responsibility
Details Of Responsibilities Assigned
- To coordinate with different departments i.e. Formulation Development (FDD), Analytical Development (ADD), Packaging Development (PDD), Production, Engineering, Quality Control, Quality Assurance, Supply Chain, Business Development, Project Management and any other department for the timely execution of the New projects
- To plan for the Trial, Scale up and Exhibit batches of the New Projects.
- To oversee manufacturing of trial /scale up/exhibit/characterization/process validation batches.
- To plan and monitor the Pre- validation/characterization batches.
- To review / approve documentation like trial batch objective, trial batch BMR, protocols (for Trial, CH, PV any other) and respective reports, justification, regulatory query response, write up for any recommendation / data compilation, study protocol / report etc.
- To prepare the Justification/Investigation/Technical report for any failure/deviation/event observed during the execution of the Exhibit batches.
- To arrange for the readiness of the New Product Launch.
- To investigate and resolve the Trouble shooting projects in collaboration with Production and QA.
- To prepare technical justification / review the response for the regulatory query.
Key Skills
Deep Technical Knowledge
Process Engineering
Stakeholder Management
Regulatory Compliance
Cross-functional Collaboration
Risk Assessment
Travel Estimate
Yes, to multiple sites
Job Scope
Internal Interactions (within the organization)
FRD, ADD, PMO, Mfg.
External Interactions (outside the organization)
Vendors, CMOs
Geographical Scope
Global
Financial Accountability (cost/revenue with exclusive authority)
Job Requirements
Educational Qualification
M. Pharm
Specific Certification
Skills
Experience
20+ Years
