Work as Senior Executive – Quality Assurance at United States Pharmacopeia (USP) - India
The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years.
Post: Senior Executive – Quality Assurance
Function of the Position:
This is a non-supervisory professional position responsible for support to the various activities of Quality Assurance. Coordinating with the laboratory function in maintaining the Quality management systems. The details of the Job duties are listed. The overall objective of the position is to verify, maintain and continual improvement of quality management systems in USP-India.
Roles and responsibilities:
• Conducts Quality Assurance activities in the laboratory area as directed by appropriate standard operating procedures / ISO standards.
• Ensures the monthly targets of the project (documentation review i.e. Analytical project review), and internal audits are achieved and maintain the corresponding database up to date
• Ensure the documentation compliance of calibration and validation of equipment used for the evaluation of reference standards.
• Conducting various types of audits (Facility, and Internal audits), prepare audit reports and maintain the corresponding database up to date.
• Preparation of trends on regular basis for all the QA activities.
• Coordinating with internal cross functional groups for the projects review and other activities.
• Preparation of training modules and conducting training to staff on GMP, GLP and in house procedures.
• Approval of all QA documentation in absence of QA Manager.
• Assisting in all other day-to-day QA activities.
Master’s degree in Science with 5 plus years relevant experience in a pharmaceutical industry, preferably working in API or formulations industry.
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