Sr. GM - MSTG Orals

Job Title

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Function

Sub-function

Manager’s Job Title

Skip Level Manager’s Title

Function Head Title:

Location:

No. of Direct Reports (if any)

Date Of Joining

Job Summary

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

Travel Estimate

Job Scope

Internal Interactions (within the organization)

External Interactions (outside the organization)

Geographical Scope

Financial Accountability (cost/revenue with exclusive authority)

Job Requirements

Educational Qualification

Specific Certification

Skills

Experience