Job
Description
Role & responsibilities 1. Responsible for ensuring that a functional program exists for performing and monitoring instruments/equipment calibration, validation and preventative maintenance and that all instruments/equipment utilized are adequately inspected, maintained, validated, calibrated as per cGLP and SOPs. 2. To monitor quality control operations in the laboratory and oversee record keeping practices, personnel, instruments, method validation and documentation, sample tracking and storage. 3. To record and track quality control within the laboratory to identify problems and areas requiring improvement. 4. To audit the conduct of projects, representative data as well as to review the final project reports. It is to assure that they accurately describe the methods, protocols and SOPs used and that the reported results accurately reflect the raw data. 5. To determine that no deviation from approved protocols or SOPs were made without proper authorization and documentation. The QAU should review the SOP deviations for compliance issues. 6. To participate in inspections by clients and accrediting or certifying agencies. 8. To perform general and safety audits of the facility, including Archives. 9. To prepare and sign a quality assurance unit statement, which will document the dates of audits and verifications of corrective actions. This statement is to be included with the final project report. 10. To prepare periodic summary report of QC & QA activities for director review. Spot check and review the laboratory records, notebooks, calculations, chain-of-custody forms, final report, sample handling, sample storage, and all others matters related to sample analysis. Record results of such checks and review in a notebook reserved for such QA records. 11. To keep a copy of all SOPs and protocols for which the QAU is responsible. A log containing all versions of SOPs excluding analytical procedures is to be kept and updated by the QAU. 12. Responsible for the management of SOPs. This management includes the distribution to the operations, change control, review procedure, and approval for compliance of the SOPs. 13. To keep a copy of the master schedule (see appropriate SOP) of all projects. A log is to be kept and updated by the management. This log is to be archived annually. 14. Responsible for assuring that training programs are established and documented and that the content and frequency of the training programs supports the application of cGLP. 15. To ensure that a proper validation program is in place and functional for computerized systems and for instruments. 16. To review standard, calibrator, quality controls, and reagents preparation, validation and documentation. 17. Responsibilities and procedures applicable to the QAU, the records maintained by this unit and the method used to index these documents are to be in writing, kept up to date and archived when appropriate. Preferred candidate profile Candidate with CRO experience preferable.
