The U.S. Pharmacopeial Convention (USP) Executive Instrumentation in Hyderabad, India
- 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.This is a Non-supervisory position in Central Lab Operations department responsible for the Lab Equipment management and Equipment breakdowns of USP-India Labs.
Roles and Responsibilities
To coordinate with RSL, R&D, VER, Synthetic and Biologics departments of USP India site for all Equipment Qualification and servicing activities of the site.
To coordinate with vendors and internal departments during installation of any equipment/software in USP India Laboratory and ensure proper documentation. Responsible to ensure operational SOPs are available for all the critical equipments.
Responsible to coordinate with vendors and internal departments for the annual Equipment validations as per the validation master plan.
Responsible for preparation and review of Equipment validation protocols and reports.
To address Equipment qualification issues by coordination with vendors.
To handle and resolve breakdowns for some of the lab equipment’s.
To support In-House service engineer in resolving the critical Equipment breakdown issues.
To support and execute In-House validations and calibrations.
To update the centralized metrological databases as per the activities performed.
Responsible for issuance of Equipment log books.
Responsible to coordinate with vendors for the internal and external trainings.
To take up the additional responsibilities assigned by the supervisor.
Knowledge on trouble shooting and preventive maintenance of Laboratory equipment’s like HPLC, GC etc.
Knowledge on Laboratory compliance (GMP and GLP).
Knowledge on execution of Validation/Calibration activities for some of the equipment’s.
Strong hold on ERP, Empower, Nu-Genesis SDMS Software will be an added advantage.
B.E / B.Tech in Instrument Engineering or M.Sc. in Instrumentation with Minimum 3-4 years’ experience in a reputed Pharmaceutical company.
Job Category Scientific