Sr. GM - MSTG Orals

**Job Description:** As a Lead MSTG Orals, your role involves coordinating with various departments such as Formulation Development (FDD), Analytical Development (ADD), Packaging Development (PDD), Production, Engineering, Quality Control, Quality Assurance, Supply Chain, Business Development, Project Management, and other relevant departments to ensure the timely execution of new projects. You will be responsible for planning and overseeing the manufacturing of trial, scale-up, exhibit, and process validation batches. Additionally, you will be required to review and approve documentation, prepare technical justifications, investigate troubleshooting projects, and ensure readiness for new product launches. Your role will also involve collaborating with production and QA to resolve any issues and respond to regulatory queries effectively. **Key Responsibilities:** - Coordinate with various departments for the timely execution of new projects - Plan and oversee manufacturing of trial, scale-up, exhibit, and process validation batches - Review and approve documentation related to trial batches, protocols, reports, regulatory queries, and more - Prepare technical justifications and investigate any failures or deviations during project execution - Arrange for the readiness of new product launches and resolve troubleshooting projects - Prepare technical justifications and review responses for regulatory queries **Qualifications Required:** - Educational Qualification: M. Pharm - Experience: 20+ years - Specific Certification: Not specified **Additional Details:** - Location: Halol - No. of Direct Reports: 5 - Travel Estimate: Yes, to multiple sites - Internal Interactions: FRD, ADD, PMO, Mfg. - External Interactions: Vendors, CMOs - Geographical Scope: Global - Financial Accountability: Not specified,