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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Bio Tech / R&D / Scientist |
| EmploymentType | Full-time |
Scientist II - Analytical Research and Development Tracking Code IND 173Job Description This is a non-supervisory position in USP-India s Analytical Research & Development Laboratory. In this role , the Scientist - II works on projects including Analytical Method Development for in process samples for synthetic chemistry support. The Scientist II performs a variety of non-routine and routine analytical tests , including evaluation of reference standards , development or validation (as per requirement) of official methods , evaluation of packaging materials and stability studies , and general research in analytical chemistryRoles and Responsibilities Support to reaction monitoring , scale up and final analysis of samples as per monograph / in-house procedures including method development if required. Prepare development reports for Synthetic Support projects. Involve in project acceptance & approvals. Execute projects per the approved test protocols if assigned. Responsible for preparation of SOPs , protocols , reports , etc. Ensure the projects requirements by coordinating with the Purchasing department. Complete ARD- (USP-NF & CDL) projects within timelines by coordinating with Manager. Responsible for preparation of the records and documents. Ensure that the calibrations of the equipment s are performed as per the schedule. Prepare , execute and complete IQ/OQ/PQ of new instruments. Indent the required glass ware , chemicals and columns for the ARD projects. Maintain GLP & implement safety procedures while working in Lab. Perform other Projects whenever free from ARD activities. Perform other duties as assigned 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 in a timely manner. Participates in USP cross-functional teams as appropriateRequired SkillsProficient with pharmaceutical testing requirements involving compendial methods for reference materials. Expert in HPLC and GC analysis and troubleshooting , proficient in other related analytical instrumentation (IR , KF , UV , and thermal analysis techniques etc.). Knowledge of handling LCMS and GCMS will be added advantage. Working knowledge of computer applications , such as MS Word and MS Excel are required. Good interpersonal skills and proven ability to function in a team-oriented environment are necessary. Proven track record of consistently delivering projects on time and with high quality. Prior experience in a high volume pharmaceutical ARD laboratory or contract pharmaceutical analytical laboratory testing organization is a plus. Takes personal responsibility for delivery of projects to customers. General chapter information , Empower and NuGenesis will be preferredRequired Experience MSc. in Analytical Chemistry / Organic Chemistry , from a well-recognized University in India or abroad and required not less than 4 years experience in Analytical lab. Must have hands on experience in working with chemical methods and handling instruments like HPLC , GC , FTIR , UV-Visible , wet chemistry , etc. Good technical writing and verbal communication skills are required. Good interpersonal skills and proven ability to function in a team-oriented environment are necessary. Understanding of GMP / ISO-IEC 17025 Guidelines is a requirementJob Location Hyderabad , Andhra Pradesh , India Position Type Full-Time/Regular Job Category Scientific,
Keyskills :
hplc api research calibration documentation echnicalwriting gcanalysis analyticalmethoddevelopment thermalanalysis researchdevelopment deliveringprojectsontime deliveryofprojects wetchemistry iso9001