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sun pharma industries
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Sr. GM - MSTG Orals

Sr. GM - MSTG Orals

sun pharma industries

7 - 13 years

9 - 15 Lacs

kalol

Posted:14 hours ago| Platform:

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Skills Required

supply chain product launch manager quality assurance analytical project management risk assessment production engineering senior vice president manager quality control stakeholder management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Title:

Lead MSTG Orals

Job Grade:

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)

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

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