Third party operation head

Role & responsibilities

1. Drive product robustness for all products in area of responsibility and lead the third party operation team.

2. Lead and manage all TPO Process activities and process validation for products developed and manufactured at outside contract facilities.

3. This includes, providing product stewardship by ensuring the performance of all products are monitored and maintained in a validated state, supporting root cause investigations by providing Technical intelligence to deviations, technical complaints, OOS & CAPAs.

4. Identifying and executing continuous improvement opportunities, leading New Product Launch third party teams and leading technical activities related to transfers of Drug Product Manufacture and Packaging.

5. Be familiar with statistical tools to analyze data.

6. Provide third party and techno-commercial leadership in the areas of production and packaging process and process optimization using pharmaceutical processes.

7. Knowledge of all pertinent technical information related to an assigned product.
Detailed knowledge of the operation, maintenance, and utility of all manufacturing and/or packaging equipment for assigned projects.
Thorough familiarity with cGMPs, SOP's, relevant government regulations, and current industry standards.

8. Responsible for Techno-commercial activities for all dosage form.

9. Responsible for Sourcing / coordinate with LL/TP manufacturers for product related documents.

10. Supplier Identification:
• Identifying potential suppliers capable of meeting the quality, regulatory, and supply requirements for markets.

11. Supplier Qualification and Onboarding:
• Developing and implementing a robust supplier qualification process to ensure that selected suppliers meet the necessary standards and regulations in coordination with quality team.

12. Supplier Relationship Management:
• Building and maintaining strong relationships with key suppliers based on trust, transparency, and collaboration. To identify new potential vendor for product manufacturing and outside testing laboratory for method development as per requirements.

13. Risk Management:
• Identifying and assessing risks associated with third-party suppliers, including supply chain disruptions, quality issues, regulatory compliance issues, and geopolitical factors.

14. Continuous Improvement:
• Monitoring supplier performance against key performance indicators (KPIs) and benchmarks.

Regulatory Compliance:
• Ensuring that all third-party suppliers comply with relevant regulatory requirements, including Good Manufacturing Practices (GMP), Good Laboratory Practices, Good Distribution Practices (GDP), and other applicable regulations.