Application for the post of “Project Coordinator and QC Executive” in Clarion – under Tata Medical Center, Kolkata
JOB SUMMARY: - Coordination between multiple departments (Manufacturing, QC, QA and Clinical team) for smooth functioning of the project, Ware house management and QC analysis.
Experience (MSc./M.Pharm with minimum 1.5-3.0 yrs. of experience):- Should have experience in working with QC lab in a cGMP set up. - Method validation/verification protocol, reports preparation and execution - Routine operation, troubleshooting and maintenance of various manufacturing equipment in the cGMP facility. - Identification and handling of OOS/OOT, investigation, Root cause analysis, Deviation and CAPA. - Able to prepare protocols and reports pertaining to qualification of process and product. - Experience in documentation (SOP, EOP, STP, DRS etc), following GDP is a must. - Should have experience in performing above mentioned techniques independently along with data analysis and compilation. - Experience in Warehouse management is preferred MAIN DUTIES & RESPONSIBILITIES:- Coordination between multiple departments (Manufacturing, QC, QA and Clinical team). - Warehouse management- Raw material/Ancillary material/Packing material receipt & inventory management. - Method validation/verification protocol, reports preparation and execution -
Identification of OOS/OOT, investigation, Root cause analysis, CAPA.
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Responsible or Instruments/Equipment IQ/OQ/PQ, periodic calibration o performance verification.
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Strictly follow Good Documentation practices, data recording and Data Integrity,
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QC analysis of Cell therapy Products Ensure resources are in stock. Ensure instruments are maintained in a qualified state with essential calibrations and performance verification. Assist superior in preparing facility budget, planning, evaluating and implementing facility procedures and systems. Prepare presentation and give update on the work in progress to superiors.
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