Validation Engineer
Kashiv Biosciences LLC · Ahmedabad, Gujarat, INDIA
Description Greetings from Kashiv Biosciences! We are looking for Qualification, Validation and QMS Engineer for our Engineering Team in our Biosimilar Manuf...
Job description
Description Greetings from Kashiv Biosciences!!!!: We are looking for Qualification, Validation and QMS Engineer for our Engineering Team in our Biosimilar Manufacturing facility based out of Ahmedabad. Below are the roles and Responsibilities. Roles and Responsibilities: Interested candidate please share the resume on my mail id manan.hathi@kashivindia.com - Responsible for Engineering compliance, Equipment Qualification, Validation and QMS activity. - Timely escalation of any challenge bottle necks pertaining to engineering compliance to the management (site leadership team) to ensure proper planning and solutions. - Representing as a Subject Matter Export of Engineering department in front of regulatory auditors. - Responsible for engineering investigations pertaining to equipment failures and ensure for proper root cause identification and CAPA effectiveness . - Responsible for technical agreements with vendors who have work at Plant premises. - Responsible for preparing and review the master list of equipment, instrument along with the preventive maintenance & calibration scheduled . - Responsible for change control/deviation management/CAPA Through Quality management System....