Senior QC Analyst
ROLE
* Routine and Non-Routine Analysis, Using HPLC and Other Analytical Techniques
* Testing of Raw Materials, Finished Products, Stability Samples, and In-Process Samples
* Accurately Review and Interpret Analytical Results
* Ensure Laboratory Documentation is Completed in Compliance with GMP and Data Integrity Requirements
* Support OOS, OOT, Deviation, and CAPA Investigations
* Participate in Method Validation, Verification, and Transfer Activities
* Maintain Compliance with SOPs, GMP, ICH Guidelines, and CFR Requirements
* Assist with Laboratory Housekeeping, Calibration, and Equipment Maintenance
* Work Collaboratively with Other Site Departments
REQUIRED
* Degree in Chemistry or Pharmaceutical Sciences
* Minimum 5 Years’ Experience in a Pharmaceutical QC Laboratory
* Hands-on HPLC Experience
* Experience with a Variety of Analytical Techniques eg UV, FTIR, and Karl Fischer
* Sound Knowledge and Experience of GMP, Data Integrity, and Regulatory Compliance
* Experience with Chromeleon or Similar CDS Software
* Strong Analytical and Problem-Solving Skills
* Good Documentation Skills
* Ability to Work Independently and Manage Priorities Effectively
* Experience with Stability Studies and Method Validation
* Exposure to Investigations, Including OOS/OOT