A perfectionist with the ability to plan, schedule, monitor and review activities of operations, validation and compliance across product lines as per SOPs and cGMP guidelines taking into consideration the established quality policy. I have experience in implementation of quality systems, monitoring process validation, maintaining QS documents, participating in internal audits & training of departmental and cross-functional personnel.
In-depth understanding of International GMPs, ICH Regulatory guidelines and have experience in DMF filing for advanced markets.
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