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I am Qualified Pharmaceutical professional with 9 years of experience in Quality Assurance, Pharmacovigilance processes and Regulatory compliance in the Pharmacological sector and Medical device sector. Proficient in initiating, investigating, root cause analysis and closure of market complaints within stipulated timelines. Skilled in documentation, verification and approval of Standard Operating Procedure (SOP) or creating new procedures. Sound exposure in process and system inspection/audit to identify non-compliance and improve efficiency. Demonstrated ability to face regulatory audits including USFDA,PIC/s, WHO Geneva, NABL India, ISO 9001:2015,ISO22715, ISO 13485: 2016 (Medical Device) and Health Canada as well as various Customer audits. Team player with ability to lead a team by example and motivate them to achieve desired objectives.
Pharmacovigilance, Pharmaceutics, Medical device
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