- Routine Analysis: Plan and execute the analysis of formulation Development and Stability samples within predefined timelines.
- Instrument Upkeep: Ensure routine calibration and smooth operation of critical laboratory instruments (HPLC, Dissolution, UV-VIS, KF).
- Method Execution: Assist in developing secure analytical methods and completing their validation and subsequent transfer to plant QC labs.
- Documentation Compliance: Prepare, review, and finalize precise technical documents, including Specifications, STPs, and analytical reports.
- Timely Delivery: Review and submit accurate analytical reports promptly to minimize project lag times.
- Supervisory Oversight (For 4-5 Years Exp): Guide junior analysts, troubleshoot technical issues during analysis, and take responsibility for primary data review.
- Cross-Functional Coordination: Collaborate closely with Formulation R&D;, Tech Transfer, and Quality Assurance teams to ensure seamless project progression.
Preferred candidate profile
- Equipment Operation &
- Calibration:
Robust hands-on experience in operating and calibrating high-end instruments like HPLC, Dissolution Testers, UV-VIS Spectrophotometer, and Karl-Fischer (KF) titrators.
- Method Development &
- Validation:
Strong foundational knowledge and practical execution of Analytical Method Development followed by Method Validation.
- Method Transfer: Experience in executing analytical method transfers to Receiving Laboratories (commercial manufacturing sites/QC).
- Compliance &
- Documentation:
Thorough knowledge of Good Laboratory Practices (GLP), data integrity, and strict documentation management systems.
- Review &
- Reporting:
Ability to prepare and review Specifications and Standard Testing Procedures (STP) in compliance with In-house and various Pharmacopoeias.