• To ensure cGMP compliance at manufacturing facility [PR, PR (SRP), Quality units, HR, EHS, ST, EG departments] as well as to ensure the whether they are following the standard procedures. • Responsible to ensure online documentation, online data filling, and to ensure whether approved procedures are followed to ensure the data integrity and compliance as per the approved procedures & cGMP in the manufacturing facility. • Responsible for line clearance for product changeover of pharma area. • Responsible for compliance of material movement, packing materials movement, status, storage of the raw materials and stores/ raw material warehouse facility as per standard approved procedures. • Responsible for compliance of finished material movement, status, storage and facility as per standard approved procedures. • Online checking of compliance for inward and outward recovery solvents from various blocks for distillation qty., columns, kettle, chillers, receiving tanks, storage facility along with temperature indicators and level indicators. • Ensure the compliance of engineering documents like equipment qualifications, AHU, Calibrations and preventive maintenance. • Ensure the Compliance of CAPA related to online observations, NQI internal audits, OOS and deviations. • Ensure the compliance of QA activities like change controls, Vendor management, Dispatch activities, Document control, Annual product Quality review, Process and cleaning Validations, Computerized system validations, Market complaints, but not limited to mentioned areas to comply approved procedures. • Ensure the compliance of HR/Admin, EHS, and Supply chain as per the approved procedures. • Review of NQI, ensure the CAPA and closure of the same.
