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- 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 units
Quality Assurance Manager - New Delhi, India - MG Lifecare
Description
The job requires 50% travelling and 50% office based work located at Delhi