Industrious, Enterprising and Highly accomplished Analytical Lab Manager credited with 12+ years of experience in the field of Pharmaceutical Quality Control and Analytical R&D. Outstanding strategist and creative problem solver distinguished for demonstrated leadership and team building skills and excellent communications abilities.
Areas of Expertise include
- Experience with UV-VIS Spectroscopy, HPLC, UPLC, GC, GC-MS/MS, ICP-MS, FTIR, Dissolution apparatus, Polarimeter, Karl Fischer, TGA, DSC, XPRD and other basic Chemical and Analytical Techniques.
- Experience in Method development, Method Validation and Method Transfer.
- Extensive knowledge of cGMP, Data Integrity and Compliance guidelines provided by FDA.
- Extensive knowledge of regulatory (ICH, FDA, EMA) and compendial guidance and practical experience in meeting requirements in all phases.
- Expertise in analyzing Finished Products, In-Process Samples and Raw Materials and Stability Samples
- Experience in writing and reviewing Analytical Method Validation Protocols and Reports.
- Experienced in resolving OOS or OOT investigations.
- Experienced in Calibration of analytical instruments and routine maintenance.
- Experience in troubleshooting on chromatographic instruments.
