Analyst, Global Stability
endo · India - Pudupakkam ·
- Experience
- 3+ years
Job Description Summary
QC Analyst with 3–6 years of experience in pharmaceutical quality control, skilled in routine in‑process samples, and finished products. Experienced in instrumental analysis (HPLC, GC, UV, Dissolution), method execution as per approved SOPs, OOS/OOT investigations, and data integrity compliance. Well‑versed in GMP, documentation practices, and regulatory guidelines, with strong analytical and problem‑solving skills.Job Description
- Perform routine QC testing of raw materials, intermediates, and finished products using approved analytical methods.
- Conduct instrumental analysis including HPLC, GC, UV–Vis, Dissolution, and wet chemistry techniques.
- Execute stability studies, compile data, trend results, and prepare stability reports.
- Review and ensure accuracy, completeness, and compliance of analytical data and documentation.
- Handle OOS, OOT, deviations, and laboratory incidents, including root cause analysis and implementation of CAPAs.
- Ensure compliance with cGMP, data integrity (ALCOA+), SOPs, and regulatory guidelines.
- Support method transfers, method verifications, and analytical method validations as required.
- Maintain laboratory equipment, perform calibrations, and ensure proper documentation of laboratory activities.
- Participate in internal audits, regulatory inspections, and continuous improvement initiatives.
- Coordinate with cross‑functional teams such as QA, Manufacturing, and Regulatory Affairs as needed.
- Proficiency in laboratory documentation and electronic systems (LIMS preferred).
- Good problem‑solving, analytical, and communication skills.
- Ability to work independently as well as collaboratively in a regulated environment.