Bengaluru
INR 10.0 - 15.0 Lacs P.A.
Work from Office
Full Time
Responsible for planning and execution of API and intermediates according to pre-approved instructions and raw materials, manpower according to the requirementResponsible for prepare, approve, improvement, continuous review and upgradation of existing production SOPs.Responsible for change controls, deviations / OOS / complaint / OOT, validations, qualifications, calibrations and investigations and evaluations. Trainings and implementing cGMP & Safety, Hygiene in production areas. Responsible for handling of Spray dryer and Homogenizer.Facing the customer audits, regulatory audits and conducting self inspections inter departments New product introduce in the plant and establishment the process for commercial with the help of R & D. Review of technology transfer documents related to production and implement accordinglyResponsible to ensure material handling without spillage and to protect product and deterioration.Involvement in quarterly and Annual product quality review.To Conduct, HAZAOP and Risk assessment of product, system, equipment, item, process as per standard procedure.Ensure Strict adherence to safety, health & environment.Ensure Data integrity
Bengaluru
INR 6.0 - 8.0 Lacs P.A.
Work from Office
Full Time
JOB RESPONSBILITIES ON QUALIFICATION OF EQUIPMENT, FACILITY & UTILITIES - QA RESPONSIBILITIES: Ensuring of preventive maintenance of all equipments carried out as per schedule. Review of calibration certificates. Review of all equipment and utilities qualification documents (URS,IQ,OQ and PQ). Review of requalification protocol and reports for all equipments as per schedule. Review of temperature mapping protocol and report as per the schedule. Preparation of product quality review as per SOP. Review of preventive maintenance and calibration schedules and checklist. Issuance, retrieval and archival of registers to respective departments. Line clearance for equipments, clean room area and repacking area during product-to-product change over. Review of Water analysis reports and Microbiology reports. Ensure Data integrity. Conducting trainings. Review and compliance of engineering department and conducting GMP walk through audit. Preparation and review of Standard Operating Procedures. Involving in investigations and review of Deviations and others QMS activities. Involving in Internal audits. Handling of document control system.
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