Job Description

Experience : 4 to 8 Years of experience.
Location : Chennai
No. of Position: 3
Industry : Pharma Production / Biotech
Qualification : Biotechnology/ Microbiology/ Pharma
Gender : Only Male candidates
Skill set : USFDA / MHRA / GMP / (AATB or AABB) Audits faced.
GMP/Clean Room, Sterile Experience Mandatory.
Excellent communication skill required.
The major responsibilities include: 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. 11. Verifying and compiling the monthly product status/ Deviation /Consolidated report of all products and sending it to Quality Assurance - Head. 12. Close monitoring of the collection, processing, and storage activities with respect to sample deviation, Training, Sample status, verification of final preservation certificate, and other issues related to samples. 13. Checking of the medical kit box assembly and verification of the same before dispatch to clients. 14. To check the in-house material preparation and send the status to Quality Assurance - Head.