Scientist II, RSL
Location: Hyderabad, India
Job Category: Chemistry & Scientific Standards
Job Type: Full-time
Req ID: SCIEN002702
Job Overview:
The Scientist II in Reference Standard Laboratory (RSL) will perform required tests as part of the project, ensuring the maintenance of a GLP-compliant environment in the laboratory. The role involves utilizing technical expertise in pharmaceutical analysis and working collaboratively with the team to ensure effective and efficient laboratory operations.
Key Responsibilities:
Test Execution: Perform analytical tests assigned by the Project Leader or Group Leader, ensuring timely project completion and addressing any scientific issues that arise.
Project Coordination: Work closely with the group leader to ensure team projects are completed on schedule.
Sample Management: Manage sample archival, tracking, and chemical inventory. Ensure availability of necessary chemicals and columns for ongoing projects.
Equipment Calibration: Perform calibration of lab equipment as per the established schedule.
Documentation: Prepare, execute, and complete IQ/OQ/PQ for new instruments, and review and prepare SOPs, protocols, and reports.
Project Reviews: Conduct initial reviews of project reports and assist the group leader as required.
Safety and Compliance: Maintain laboratory safety and GLP practices, ensuring compliance during internal and external audits and certifications.
Support to Other Teams: Support verification, GPH, PQM, stability, and other departmental teams with testing and project reviews as needed.
Regulatory Compliance: Follow QMS protocols, address incidents and deviations, and ensure adherence to GLP regulations.
Qualifications:
Education: Master’s degree in M.Sc. (Analytical or Organic Chemistry), M. Pharma (Pharmaceutical Sciences or Analysis) with 3 to 6 years of relevant laboratory experience.
Experience: Proven track record of completing tests on time and with high quality for formulation and APIs.
Skills:
Proficiency in chromatographic analysis, particularly HPLC and GC.
Experience with related analytical instruments such as Auto titrator, KF, FTIR, UV spectrometer, Thermal equipment, Elemental analyzer, TLC, etc.
Proficiency in wet chemical analysis.
Effective communication skills, both written and verbal.
Expertise in Empower software with knowledge of audit trails and custom fields.
Strong technical and analytical problem-solving skills.
Strong understanding of GLP regulations and experience with external regulatory audits.
Additional Desired Preferences:
Knowledge of Lab Management System (LMS), Electronic Laboratory Notebook, ERP, QR coding system.
Hands-on experience with MS instruments.
Understanding monograph procedures and experience with compendial methods for reference materials (USP, FCC, NF).
Prior experience in a high-volume pharmaceutical manufacturing QC lab, Analytical R&D, or contract pharmaceutical analytical laboratory.
Awareness of ISO/IEC 17025 is desirable.
Benefits:
USP offers a comprehensive benefits package, including company-paid time off, healthcare options, and retirement savings, providing peace of mind for employees' personal and financial well-being.
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