Position Overview
Job Description
The Quality Assurance Data Reviewer is a position reporting to the QA Director and is responsible for ensuring the compliance with applicable regulations (i.e. GMP, Health Canada and FDA regulations), for clients requiring quality assurance services.
Responsibilities:
Perform data review of batches carried out in laboratory, including raw data review and calculations;Perform data review of method validation and method transfer projects as well as organize final validation packages for clients;Perform data review of local Method Development and/or Verification Reports;Prepare/Review/Check Instrument/Equipment Qualification protocols and reports;Review and approve calibrations and preventative maintenance;Ensure GMP compliance; Apply and follow the data integrity procedures;Ensure reports follow designated SOPs and comply with GMP;Ensure corrections are compl...