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Laboratory Quality Assurance Document Reviewer

2 months ago

Concord Ontario, York region, Canada AX Pharmaceutical Corp Full time

The main responsibility of the Laboratory Quality Assurance Document Reviewer is to ensure completion, review and archiving of all relevant GMP documentation for AX Pharmaceutical API testing for release and stability, and laboratory support and maintenance functions which must meet company and regulatory GMP requirements for release, re-labelling, repackaging, and testing. The individual will further assist with investigations, internal audits, and CAPA response planning and execution.


Principal Duties and Responsibilities:

• Review method validation plans and report data.

• Schedule equipment maintenance by third party vendors according to maintenance schedule. Review and sign-off on equipment qualification/calibration protocols and documentation from third party vendors.

• Review qualification documentation for third party vendors (equipment maintenance and testing)

• Review deviation reports and write CAPA response plan. monitor and follow-up CAPA completion status and perform effectiveness checks.

• Monitoring and follow-up of change control action items and effectiveness checks.

• Assist with and review of OOS investigations.

• Review instrument audit trails.

• Provide support for internal audits.

• Weekly review and monitoring of conditions in stability chambers.

• Stability study program monitoring.

• Manage laboratory glassware calibration and cleaning validation programs.

• Identify and implement process improvements for continuous enhancement of quality systems at the company.


Knowledge, Skills and Abilities:

• Minimum 2-3 years experience in a quality role in the pharmaceutical industry, laboratory experience preferred

• Sound knowledge of Health Canada and FDA pharmaceutical regulations. Specifically, GUI-0104 Good manufacturing Practices Guide for Active Pharmaceutical Ingredients, and 21CFRPart210 and Part211 for Current Good Manufacturing Practices in Manufacturing, Processing, Packing, or Holding of Drugs; General

• Knowledge of ICH regulations, specifically ICHQ7A, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. Knowledge of ICHQ9, ICHQ1A, ICHQ12, ICHQ3A, ICHQ9 an asset.

• Knowledge of chemistry techniques used in the pharmaceutical lab including but not limited to FTIR, UV-VIS, HPLC, GC, Karl Fischer water determination, titrations.

• Knowledge of Agilent Chromatography Data System (CDS) an asset

• Knowledge of Mettler-Toledo LabX software an asset

• Proficient in Microsoft Word, Excel