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 completed in a timely manner and released promptly as required;
- Ensure appropriate analyses conducted and proper method followed, and method modifications are applied and followed;
- Verify that all results reported are within specification;
- Display proper judgment during investigations;
- Troubleshoot and respond quickly when problems arise;
- Any other duties assigned by Supervisor.