Job Description

Experience: 0 – 5 Yrs. Qualification: MS-Regulatory affairs, Diploma in Regulatory Affairs, M Pharmacy, B.E Biomedical engineering, M.sc Biotechnology, M.sc Microbiology & graduation/post-graduation in any related scientific discipline
you shall:

• Support implementation, development, maintenance and control of a quality management system according to international standards and corporate guidelines/policies/procedures and applicable regulations for certification held by the client
• Prepare annual AMC calendar under the supervision of department head
• Conduct Internal Quality Audit and Management Review Meeting at intervals defined in QMS of the client
• Prepare and Support client for re-certification and surveillance audits
• Ensure closure of non-conformities observed during such audits, verify implementation of such corrective actions, and maintain relevant evidence.
• Maintaining clients technical documentation, assure an effective, consistent and reliable forward of information in terms of product surveillance
• Visit client premises at frequency defined in the AMC calendar, support their routine activities, and provide appropriate guidance
• Prepare monthly follow ups for Post market data and monthly status report with details of all activities performed for a specific AMC client
• Prepare PMSR, PSUR, PMCF report, Analysis of data, on annual basis based on the data received from the client
• Update MAUDE, MHRA and information retrieved from other databases along with Sales, complaint and audit data in the Clinical evaluation on annual basis
• Update risk if any new hazards or hazardous situation are identified during routine production and post production activities
• Review customer feedbacks, customer complaints, distributor agreements, supplier evaluation and re-evaluation, training records, quality objectives routine batch manufacturing records, calibration records, and preventive maintenance schedule.
• Verify Corrective Action Reports against customer complaints and Internal Quality Audit.
• Continuous communication with the client to address their concerns w.r.t scope of AMC