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Quality Assurance Manager

5.00 to 9.00 Years   Delhi   19 Jun, 2024
MG Lifecare
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaNot Mentioned
EmploymentTypeFull-time

Job Description

    To evaluate and ensure the quality level of Intermediate material, Active Pharmaceutical Ingredient & Excipient, Finished Products manufacturer (sterile/ non-sterile), Packaging Material Manufacturer by conducting GMP audits including timely audit report preparation, and follow-up for CAPA To arrange and co-ordinate audits in India and out-side India as per schedule To participate to audit program creation and follow-up and maintenance of vendor status To be responsible for conduction of audits of Contract Manufacturing and Contract Research Organizations and follow up for the compliance including compliance audits To do the vendor qualification for Raw Materials (API, excipients, intermediate), Packaging Material manufacturer and continuously monitor the quality of the products supplied by them To conduct the various audits as per the requirement from R & D Department and Medicinal Chemistry department from time to time To conduct the triggered audits of the basis of. the quality mishaps such as complaints, regulatory warning letters, OOS, recalls and returns, if any for contract manufacturers and other vendors To assist and support in the various projects undertaken by Head quarter Finland from time to time To maintain liaison between the various vendors To execute of goals and schedules in own area of responsibility as agreed To take the other responsibilities from time to time as suggested by Higher Management To oversee daily production and batch release at various manufacturing unitsThe job requires 50% travelling and 50% office based work located at Delhi,

Keyskills :
CAPAVendor qualificationQuality monitoringAuditingRegulatory complianceGMP auditsAudit program creationCompliance auditsVendor status maintenanceRaw Materials qualification

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