Managing the entire QA activities in the plant & Overall implementation of Quality Systems in all units.
Design, Develop and approve all Quality systems in all units. Monitoring, Documentation, and implementation of process development.
Responsible to handle regulatory audits USFDA ISO 9001-14001, EU,WHO, and their compliance in all units without any Major Non Compliance.
Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate; and Performing product quality reviews
Handling of statutory audits like Quality, EHS, KSPCB, -CDSCO, weight & scale inspector, Director of Factories & Boilers, Social audits etc and their compliance (Evaluated by No show cause notice and no complaints)
Making sure that critical deviations are investigated and resolved;
Approving all specifications and master production instructions, Test methods, Qualifications
Approving all procedures impacting the quality of intermediates or APIs
Making sure that quality related complaints are investigated and resolved
Adhering to QA budget.
To qualify company for various certifications.
Assuring QMS in all Units.
|15 - 20 Years
|Pharma / R&D / Biotech
|Quality Assurance Supervisor USFDA Compliance and Audits Pharmaceutical Quality Assurance
MNC ( Product Base Company)
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