Gmp Coordinator- Centre For Ocular Regeneration (core), Brien Holden Eye Research Centre Job in L V Prasad Eye Institute

Quality Assurance

• Preparation of QA, QC, Equipment, Stores and General SOPs.
• Training GMP personnel on GMP requirements and all SOPs related to GMP activities.
• Preparation of Site Master File, Master Formula Record and product and process related documents.
• Allotting Equipment code or number whenever new equipment received in GMP facility.
• Preparation of Calibration and requalification calendar for all equipment and AHU of GMP and GLP facility.
• Verification and maintenance of installation and other qualification documents when new equipment is installed.
• Follow up with suppliers or vendors related to reagents or equipment quotation, procurement, installation and training.
• Identification of GMP compliance raw materials, reagents for cell culture activity.
• Preparation and facing external and regulatory audits.
• Review of BMR and batch release for non-clinical and animal studies.

Regulatory

• Coordinate with regulatory consultant for preparation of required documents for submission to DCGI related to academic and clinical trial approvals.
• Preparation of dossier related to stem cell product for academic and clinical trial approvals not limited to Study protocol, Inform Consent Form, Case Report Form, Investigator Brochure, Monograph and cover letter.
• Pre audit training for all GMP personnel during DCGI or any other regulatory inspection.
• Readiness for regulatory or external inspection as per the respective audit checklist.
• Applying online for Test license from the state Drug Control Administrator and regular follow up with drug inspector for timely inspection and test license approval.
• Preparation and compilation of query response for all regulatory quires raised by DCGI by following up with concerned stake holders.
• Identification and gap analysis with respect to regulatory approvals requirement for new products like stem cells and coordinator with respective PI/Scientist for document preparation and submission to regulatory bodies.

Quality Control

• Identifying reagent kits and vendor for procurement of test kits related to stem cell specification.
• Training QC personnel related to BET, Mycoplasma, Microbial monitoring and other QC procedures.
• Identification and sample sending for external labs for special tests.
• Setting specification for each starting materials, raw materials, in process and final product as per stem cell and regulatory guidelines.