Opening for Senior Executive – Quality Assurance in The United States Pharmacopeia (USP)

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

Job Description:
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 audits, Method audits, Process audits, Facility inspection and internal audits are achieved and maintain the corresponding database up to date
• Ensure proper calibration and validation of equipment used for the evaluation of reference standards.
• Prepare the facility inspection reports, project documentation audit report and maintains the respective databases.
• Issuance of Laboratory Notebooks and maintain corresponding database.
• Conducting various types of audits (project documentation, Facility, Method, Internal and Process audits) 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.
Authorities
In absence of QA-Manager, he will be designated and authorized to approve all the QA documents

Candidate Profile:
Master’s degree in Science with 5 plus years relevant experience in a pharmaceutical type industry.
Knowledge, Skills, Abilities:
Working knowledge of MS Word, Excel and Access are required. Excellent problem solving skills as well as excellent technical writing and auditing skills are required. Candidate must understand GMP, GLP, and ISO regulations and the integration of the regulations into working systems in the laboratory.
Frequent contacts:
Sr. Manager – Quality Assurance
RSL / ACR / ITAP / VER
Internal USP Departments
Internal Cross Functional Groups

Additional Information:
Experience: 5-10 years
Location: Hyderabad-India
Education: B.Sc - Bio-Chemistry, Chemistry ; M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: QA