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Job Opening details:-
Company Name :- USP (U.S. Pharmacopeial Convention)
Position Name :- Scientist I, RSL
Company Location :- Hyderabad, Telangana
Job Category :- Jobs in Hyderabad
Full Job Description :-
Description
Conducts stability testing for reference standard candidates using appropriate methods.
Records experimental data, ensuring clear and accurate transcription of results and calculations.
Prepares stability reports, evaluates chemical stability trends, develops predictive stability models based on stability data.
Stability chambers monitoring and management including qualifications and calibrations as per the regulatory requirement.
Hands on experience on Stability chambers risk management mitigation plans.
Verification of test protocol and giving approvals, whenever required.
Responsible for preparation of project evaluation reports for all the lab testing whenever required.
Responsible for sample tracking, chemical inventory tracking and archival of samples in the laboratory.
Coordination with Project or Group Leader to ensure completion of the projects allotted to the team.
Initial review of the project reports and documents and assisting the Project or Group Leader when required.
Completing the project as per the timelines and trouble shoot the scientific aspects of the projects on need basis.
Responsible for preparation and review of SOP’s, protocols, reports etc.
Responsible for performing the calibration of the Equipments as per the schedule.
Responsible for preparing, executing, and completing IQ/OQ/PQ of new instruments.
Preparation and planning for ISO-9001 & ISO- 17025 certification/recertification by participating actively and take an active role in the internal as well as external QA audits and address the audit issues in a timely manner.Ensuring that the chemicals and column etc. are available for the projects and forward the purchase requisitions.
Taking up any additional responsibilities assigned by group leader from time to time.
Ensure all lab safety and GLP practices are maintained in the lab and participate actively in the internal and external audits and certification.
Supports RSL, CSU, Verification, GPH, PQM, and other departmental teams in terms of testing and project review whenever required.
Basic Qualifications:
Education:
Master’s degree in Analytical chemistry or in Pharmacy. Experience :
Minimum 2 to 4 years of relevant laboratory experience.
Preferred Qualifications:
Proven track record of consistently delivering projects on time and with high quality. Proficient with pharmaceutical stability testing requirements and test protocols involving compendial methods for reference materials (USP, FCC, NF, etc.). Expert in Pharmaceutical Stability Chambers Management, Chromatographic analysis, especially in HPLC, GC and troubleshooting, proficient in other related analytical instrumentation (Titrations, IR, KF, UV, Thermal, Elemental analysis etc.), Takes personal responsibility for delivery of projects to customers. Ability to embrace and lead change. Extremely adaptable. Excellent communication skills, both written and verbal. Having knowledge of Empower software, Lab Management System and Electronic Laboratory Notebook, 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.
Supervisory Responsibilities:
No About USP : The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Note: As a condition of employment with United States Pharmacopeia- India Private Limited’s (USP), duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after November 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved.
Job Category Chemistry & Scientific Standards
Job Type Full-Time
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