Job Description
Job Description
The Quality Assurance Data Reviewer is a position reporting to the QA Director and is responsible for ensuring 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 comp...