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Scientist Ii, Rsl

3-6 years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: M.Sc./M.Pharm/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.