Executive, Indore

Job Description Qualification Review: Qualification and validation of Instrument and Equipment's, utility and facility Cleaning Validation Conduct worst-case assessments. Perform MACO calculations, and prepare protocols and reports tracking Activity Tracking Monitor schedules for re-qualification, preventive maintenance, calibration, and validation.Position / Job Title - Executive Department - Quality Assurance– Qualification, Cleaning validation Reporting To - Senior Manager- Quality Assurance Years of Experience - 5-8 Years Dosage Form - Solid Oral Location - Pithampur Job Responsibilities / Deliverables - Well versed in the qualification document review which includes review ofURS, FDS, FRA, DQ, IQ, OQ, and PQ Risk assessment, GAP assessment CSV Executed document review Well versed in the cleaning validation document review which includes review of change request evaluation with respect to change in API, manufacturing process, equipment cleaning procedure, change in equipment trainRisk assessment with respect to change in cleaning process, new equipment introduction, GAP assessment with respect to current regulatory requirement Cleaning validation worst-case assessment, MACO calculation, protocol and report preparation. Tracking of cleaning validation scheduled activity Ensure all QMS are closed as per SOP timeline.Review of calibration activity as per defined schedule frequency. Review of preventive maintenance activity as per defined frequency. Review of requalification activity as per defined frequency. Preparation and review of QA department SOPs. Tracking of qualification and requalification activities and follow up activities.Independently handle qualification and validation activity. Good co-ordination skills with another department. Good knowledge about current trends of Data integrity. Good knowledge about current Regulatory Guidance and requirement Qualifications&Pre-Requisites Must have knowledge on handling Qualification and validation. Exposure to various regulatory bodies like US FDA, MHRA, TGA. Exposure to specific dosage forms like OSD. Team coordination and work distribution. Good communication skill which results to coordination with functions like QC, Manufacturing, Engineering, Warehouse Regulatory.