Harprit Kaila has an expectional understanding and background in GMP requirements from her experience working in a GMP laboratory. Harprit is a highly reliable and organized individual with exceptional written and verbal communication skills. Sher works effectively under pressure and functions well as both a team player or as an individual. Her analytical skills, work experience, and educational background add to the depth of the QCR team.
Skills and Highlights
- Applied GMP practices to perform up-to-date analytical methods (USP, BP/EP) for raw materials, excipients, pre-curosors, finished products and stability testing.
- Reviewed lab documentation, OOS/OOT and change control procedures.
- Performed deviation investigations.
- Reviewed third party lab test results, deviations and investigations.
Quality Control (QCO)
- Performed testing and method validation using HPLC, friability, dissolution, disintegration, Karl Fischer titration, melting point, potentiometric titration, pH meter, FT-IR, UV, TOC, AA, Malvern Mastersizer and various multifaceted wet chemistry procedures.
- Completed a variety of analytical testing adhering to all GMP and GLP guidelines.
- Ensured compliance was always met using approved SOPs and work instructions.
- Reported any deviations of results to supervision and assisted with laboratory investigations.
- Remained updated on all health and safety concerns in the lab and facility at all times and discuss any potential concerns with health and safety committee as required.
- Wrote SOPs to support Quality System for a GMP facility and revised as required by audit comments and CAPAs.
- Prepared procedures to bridge the gap between GPP and GMP regulatory requirements.
- Prepared audit responses addressing all critical and non-critical observations.
- Collected pertinent information to draft Site Master Files.
- Performed method validation for new materials or pharmacopeia updates by creating protocols that test accuracy, specificity, precision and repeatability.
- Calibrated and validated lab equipment.
- Trained new analysts on testing, safety, company procedures and policies.
- Maintained an up-to-date knowledge and understanding of procedures and safety guidelines at all times to ensure compliance.
- Revised training materials as regulatory updates occurred
- Post Graduate Diploma – Quality Assurance and Quality Control, Toronto Institute of Pharmaceutical Technology, Toronto Ontario.
- Bachelor of Science – Double Major in Biology and Psychology, Dalhousie University, Halifax Nova Scotia.