Responsibilities

1. To execute the planned laboratory activities in compliance with the cGMP and maintaining a safe work environment as per SHE norms.
2. To adhere with training schedule, in completion of training requirements and method qualifications.
3. To write, review of analytical method validation protocol and reports, planning and execution in compliance to regulatory norms.
4. Preparation, execution and review of technology transfer of analytical methodologies.
5. Ensure compliance towards quality systems and timely closure of QMS elements in the laboratory with thorough investigations
6. To Initiate and close change controls for system improvements and new method/system implementation.
7. To involve in compliance towards Quality Systems and timely initiation and closure of QMS elements (Deviation/OOS/OOT/incident/CAPA) in the laboratory with thorough investigations.
8. To prepare or review of SOP’s, STP’s and ROA’s.
9. Support for regulatory inspections and to support and plan for commercial release testing.
10. Maintaining instruments along with routine calibration.

Qualifications

Educational qualification: A Bachelor’s in Chemical Engineering or a Master’s in Science

Minimum work experience: 6 to 9 years of experience in working with Biosimilar Products