2 Arco Lab Team Lead Jobs

Purpose of the role: Drug Product MSAT and Technology Transfer TECHNICAL COMPETENCIES: 1. To ensure Site / Tech -transfer of products to Manufacturing site. 2. To ensure Process Performance Qualifications Role Purpose: 1. Technology transfer of in house R&D developed products. 2. Product transfers from internal and external sites to CDMO. 3. Ensure the compliance of Relevant SOPs in product transfer process. KEY DUTIES AND RESPONSIBILITIES: 1. To involve in execution of feasibility/exhibit/pre-validation/process qualification batches for 2. Technology transfer of products and site transfer products. 3. To conduct trials required to generate additional information or knowledge to support the site transfer projects. 4. Responsible to follow EHS compliance as per the site EHS policy and manual. 5. Responsible for review and approval of process performance qualification and continuous 6. process verification protocols and reports. 7. Supporting the operations team for closure of deviations by involving in investigations for commercial batches. 8. Responsible for MFR review. 9. Responsible for preparation of BMP / Trial report. 10. Responsible for Gap analysis preparation. 11. Responsible to ensure product execution checklist for new products. 12. Preparation and review of protocols or batch records for trial batch on need basis.