U.S. Pharmacopoeia(USP)
Senior Manager - Quality Assurance, India
About Authority,
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.
Job Description:
Function of the Position:
This is a supervisory and professional position. The basic responsibilities of the incumbent will be handling the entire activities of Quality Assurance. Working with all functional heads and coordinating with USP Headquarters on maintaining the quality systems, preparing SOPs and ISO audits. Focuses efforts on internal audits and supporting site USP departments for continual improvement projects based on audit results. Working with HR in identifying the training needs, scheduling, implementation and also verifying the effectiveness of the training by evaluation. The overall responsibility is to supervise the quality assurance department and verify the effective implementation of quality management systems and its continual improvement.
Roles and responsibilities
Conducts Quality Assurance in-process checks in the Reference Standards Laboratory area as directed by appropriate Standard Operating Procedures. Ensures the monthly targets of the project documentation audits, Method audits, Process audits, and internal audits are achieved. Conducts area inspections / audits to ensure compliance to ISO and GMP standards
Ensure properly calibrated/ validated equipment is used in the evaluation of Reference Standards. Works with Corporate Validation and Metrology to ensure the calibration and preventive maintenance of equipment is performed. Ensures properly calibrated/validated equipment is used in the evaluation of Reference Standards.
Works with HR to ensure that the personnel performing evaluations in the laboratory are appropriately trained. Provides training to the staff on quality topics.
Conduct reviews of laboratory paperwork and log- books to ensure all testing is appropriately documented, and issues Laboratory Notebooks and Equipment Log Books. Also, assists in laboratory investigations of unexpected results and performs internal and external quality audits..
Supports Quality Management Systems such as the Deviation Reporting, CAPA, Document Control and OOS Programs. Ensures all the Quality Assurance activities are performed appropriately and maintains QA databases and updating within the specified timelines
Acts as the key site contact for ISO 9001 and 17025 activities and all external ISO audits, and works with headquarters on resolving issues that are identified. Also is responsible for performing all internal process audits.
Trends of all the audit observations, CAPAs, Deviations, Change controls, LIRs and other QA activities. Plans appropriate continual improvement activities based on data analysis, working with Corporate QA, as necessary. Communicate to the top management and related departments about the gaps and proposing actions to be taken for continual improvement
Frequent contacts:
Vice President-International India
Internal USP Departments
Internal Cross Functional Groups
Functional reporting to Director, Global QA at headquarters
Minimum requirements:
Master’s degree in Chemistry/Pharmacy and 8-12 years of relevant experience in a pharmaceutical industry preferably working in API or Formulations Industry. Knowledge on Analytical testing background is a plus. Have thorough understanding on GMP, GLP, and ISO regulations and the integration of the regulations into working systems in the laboratory.
Knowledge, Skills, Abilities:
A sound knowledge on GMP practices, documentation familiar and exposure with internal audits, external regulatory audits required. Excellent problem solving skills as well as excellent technical writing and auditing skills are required. Auditing experience should be preferably with ISO 9001, ISO 17025, and/or cGMP. Excellent problem-solving, project management and technical writing skills are required. Good negotiation skills, critical thinking, and interpersonal skills are a must. Supervisory experience preferred. Working knowledge of MS Word, Excel and Access are required. ASQ or ISO auditor certification preferred.
Supervisory Requirements:
Executive – QA
CATEGORY: QUALITY ASSURANCE
We are proud to be an EEO/AA employer M/F/D/V. Women, minorities, veterans, and disabled persons are encouraged to apply.
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