The U.S. Pharmacopeial Convention (USP) is a scientific non-profit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Post : Senior Manager, Verification Programs
Summary of the Position
This is a supervisory position in Verification and GPH, responsible for Analytical activities for VER and GPH samples and maintaining a GLP environment in the lab. The incumbent will utilize his or her technical expertise, knowledge of pharmaceutical analysis in verification and GPH testing, efficient and effective laboratory operations.
Roles and Responsibilities
• Overall responsibility of managing the Verification and GPH programs testing activities.
• To review the QCM product documentations including validations for products undergoing verification.
• To develop effective communication with USP Rockville by attending regular calls.
• To guide a team of scientists as a part of the projects and maintaining GLP environment in the lab.
• To monitor the projects status including sample archival and disposal.
• To ensure that the projects requirements like chemicals, columns are available for projects and approve the purchase requisitions.
• To prepare test protocols for Verification and GPH samples and to coordinate with Verification and GPH teams at USP Rockville regarding the samples and testing issues.
• To prepare, review and approve the test reports.
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• Follow up the project reviews with the reviewer and QA, response to QA observations and posting them into common drive.
• To identify the training needs of team members and providing the training classes.
• To plan and implement the succession plans by training the scientists.
• Responsible for preparation and review of SOP’s and ensuring the implementation of GLP and Safety systems.
• Ensuring calibration of the equipment as per the schedule.
• Preparation and planning for ISO-9001 & ISO-17025 certification / recertification by participating actively, verification of protocols and related documents and take an active role in the Internal as well as external QA audits and address the audit issues on a timely manner.
• Taking up any additional responsibilities assigned by the Director- RSL and Verification Program from time to time.
• Master’s degree in pharmaceuticals/chemistry with minimum 12-15 years of relevant laboratory experience.
• Proficient in pharmaceutical analysis with in-depth knowledge of theoretical concepts in complex formulations and dietary supplements. Exposure in techniques like HPLC, GC, IR, KF, UV, dissolution, ICP MS, ICP-OES etc. with respect to hands on experience and troubleshooting.
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Takes personal responsibility for the delivery of projects to customers. Must have handled team of 05-06 scientists for at least 02 years. Ability to embrace, lead change helping colleagues to grow by sharing targeted, actionable feedback and new insights on a regular basis. Extremely adaptable and consistently delivers on goals and deadlines while maintaining a high level of quality and accuracy. Excellent communication skills, both written and verbal. Having knowledge of Empower software, ELN, ERP, QR coding system are added advantages. Prior experience in a high volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.
Experience : 12-15 years
Qualification : M.Pharm, M.Sc
Location : Hyderabad
Industry Type : Verification Programs
End Date : 5th May, 2020