ISO QMS 2000 Lead Auditor , IRCA Certified Provisional Auditor for ISO 9001: 2008 . Quality standards ISO 17025 awareness program.
Currently working as head QA, Ext. mfg.
Managing Quality compliance at CMO, team building, regulatory compliance, successful completion of regulatory audits
Responsible to ensure that quality systems are followed for every batch and every product manufactured at the subcontracting sites for both types of business arrangement (Toll (LL) and Full (P2P) manufacturing).
Managing the training needs of the management employees of the EM sites at the sites on Quality, Safety, Hygiene and other aspects of their skills for further development. Preparing and sharing the training modules for sites.
Managed all dosage forms injectable, tablets, capsules, cream, ointment and liquid orals manufactured by CMO. knowledge of Animal Health Care products and animal Feed Additives products for Domestic and export market. Handling export products for EU, Russia, CIS, Ukraine, Latam, Sub- Sahara markets.
Discussing and resolving quality related troubleshooting and taking release/reject decisions along with global heads. Participate in strategy building, due diligence and acquisition projects.
I am career-focused, highly self-motivated and hard-working, with strengths team-work, communication skills, problem solving, to handle challenging tasks, think strategically and use innovative solutions, simplification of work. My strong work ethic combined with my passion and dedication has helped me to reach my goals. I believe to utilize my skills and abilities to learn and grow professionally.
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