Primary Responsibility (Strategic, Operational, Financial responsibilities) 1. To carry out the qualification/ validation activities such as preparation, execution and review of qualification/ validation protocols and reports provided by Equipment/ Process/ System vendors for validating/ qualifying GMP/ GEP equipment’s at Unit-03 site of Stelis Bio Pharma.
2. Candidate should have adequate knowledge in using Microsoft OS like Word, Excel, Power point, etc
3. Candidate should have good Communication, Document Drafting and report writing skills
4. Preparation, review and implementation of Standard operating procedures, Protocols etc., pertaining to Quality Assurance Validation in line with standard guidelines, Global GMP compliance regulations and industry practices related to Biopharma industry.
5. Review of validation package documents shared by different vendors and preparing protocols as per Stelis requirement
6. The candidate should be able to prepare/ review AutoCAD drawing based on Stelis Requirement
7. Preparation support for Qualification/ Validation policies and Validation Master Plan.
8. To ensure all time readiness for Customer and regulatory audits and inspections.
9. To ensure overall quality compliance and data integrity in all activities at site, also ensure appropriate and adequate traceability.