Contact Information

T: (905) 363-1182 x 273
F: (905) 542-7981

TF: 1 (877) 877-5152 x 273
E: HKaila@qualityandcompliance.com

2550 Argentia Rd., Suite 119, Mississauga ON L5N 5R1
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Associate Consultant

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

Quality Assurance

  • 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.

Technical Writing

  • 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.

Validation

  • Performed method validation for new materials or pharmacopeia updates by creating protocols that test accuracy, specificity, precision and repeatability.
  • Calibrated and validated lab equipment.

Training

  • 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

Education

  • 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.