1.To monitor day- to-day operations of the processing/ Quality Control / Cryopreservation / stores / maintenance and other relevant department activities and document the same in the QA document / Electronic communication.
2.To initiate and review equipment qualification protocols and reports as and when required and get the same approved by Quality Assurance - Head.
3.Complies with company policies, procedures and standards.
4.Follow standards and other requirements in accordance with regulatory and accrediting agencies.
5.To review Batch Processing Records / Test requisition forms / COA for preparation of cord blood stem cells, menstrual blood stem cells, cord tissue direct and expansion and other departments and get the same approved by Quality Assurance - Head / Designee.
6.To monitor compliance of internal and external calibration status, Calibration records, preventive / Break down maintenance of equipment, electrical checks, GMP utilities maintenance, etc are all performed as per the schedules in the relevant master lists.
7.To verify any deviations in the process and report the deviations to Quality Assurance - Head.
8.To identify areas requiring corrective/ preventive actions in processing and intimate the same to Quality Assurance - Head.
9.To analyze root cause for any deviations in processing and report the results to Quality Assurance - Head
10.To Perform Document control activities and to maintain documents accordingly.