Vice president - MSTG Orals
Sun Pharmaceutical Industries Ltd.
Full time- 10+ years
- Not Disclosed
- Vadodara, India
- Post Date: Apr 12, 2024
- End Date: Jun 12, 2024
- 10+ years
- Not Disclosed
- Vadodara, India
- Post Date:Apr 12, 2024
- End Date: Jun 12, 2024
Skills:
- Operations
- Management
Job Description:
Roles and Responsiblities
- Actively engage with R&D and act as the Stage Gate for products at the Engineering Batch and Submission stage of new product introductions.
- Create, promote and improve business and technical processes. Drive global standards for validation and product robustness across all the regions.
- Develop and implement a knowledge data base system to ensure that technical transfer activities are executed and summarized with appropriate results in approved reports to support regulatory filings and tech transfers.
- Should have knowledge of Product development expertise using QbD principles and expertise in evaluating the relationships between CPP and CQAs.
- Expertise and skills to oversee Structured Root cause investigations and commercial trouble shooting including ensuring a right process is followed and CAPA identified.
- Establish process monitoring and improvements at commercial manufacturing facilities and at Contract Manufacturing Organizations (CMOs) using scientific/technical concepts and techniques in collaboration with Site Technical leaders.
- Review and approve proposals for improved manufacturing processes, implementation of PAT and other tools that enhance process robustness and state of process and product knowledge.
- Skills in product scale changes and suggesting manufacturing modifications if required with a full 360 deg impact assessment to ensure faster and smoother implementation
- Deliver agreed financial targets such as departmental budget and key performance indicators
- To coordinate with different departments i.e. Formulation Development, Production, Project Management, Quality Control, Quality Assurance, Packaging for the timely execution of the New projects (Exhibit batches) for solid dosage plants in India.
- To oversee manufacturing of trial /scale up & exhibit batches, pre –launch/Characterisation batches & process validation batches for US, Europe, Canada, emerging and India market
- To arrange for the readiness of the New Product Launch at solid dosage plants in India
- To review & respond for process related regulatory query for exhibit batches.
- To review Justification/Investigation/Technical report for any event/incidence observed during the execution of the Exhibit batches.
- To investigate and support operation to resolve the Trouble shooting projects for solid dosage plants in India. To review Life cycle management projects like batch size increase, solvent reduction etc and provide technical support to Operation for implementation of same.
- To review site transfer documents and identify Gaps and support technical part to operation.
- To support operation and quality for alternate vendor qualification as per Global & site SOP.
- Identify and improve product robustness in collaboration with QA and production.
- To conduct weekly, Monthly and quarterly review meeting with all MSTG leads and key team members of all solid manufacturing plants in India. To conduct Monthly team huddle meeting with entire MSTG team of solid oral
- To participate in various regulatory audits to support plant.
- To contribute in Team building by imparting Training to teammates to upgrade capability
- Identification and evaluation of new technologies that can make SPIL competitive in manufacturing.
Qualifications
- Advanced degree in pharmaceutics or science or engineering with minimum 15 years’ experience in the pharmaceutical drug product industry is preferred; Ph.D. or other advanced degree with comparable industry experience is desired.
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