Quality Assurance Officer GLP Analytical Services
My client is a knowledge based, science led business focused on delivering the expertise and capabilities their clients demand. We work in the pharmaceutical, biotechnology, food, environmental, agrochemical, petrochemical, chemical and consumer products sectors.
My client supports drug discovery and development in the pharmaceutical and biotechnology markets. The site in particular provides testing and specialist analytical services and consultancy to the food and environmental sectors. They also provide toxicology services to the agrochemical, consumer products, chemical and pharmaceutical industries and materials chemistry services to the petrochemical industry.
Due to sustained business growth, the Dundee site has a brand new opportunity to join the site as a Quality Assurance Officer. The Quality Assurance Officer’s function is the independent Good Laboratory Practice (GLP) monitoring of work conducted at the Dundee site as required by the regulatory guidelines employed therein.
Review Study Plans where required.
Schedule and conduct all audits as assigned.
Write up findings of Quality Assurance Audits and Inspections.
Report all audit findings to management and Study Director/Principal Investigator (as applicable).
Prepare and issue Quality Assurance Statements.
Write and review Quality Assurance Standard Operating Procedures.
Review Standard Operating Procedures for compliance with principles of GLP, as required.
Conduct computer validation audits.
Schedule and conduct external audits.
Conduct reviews of forms.
Train other personnel in all aspects of Quality Assurance Systems and Procedures as required.
Advise management of any deficiencies in Regulatory Requirements.
Host or partake in Sponsor and Regulatory visits as appropriate.
Liaise with site personnel to ensure a full understanding of regulatory requirements.