Title:

QA Systems Leader (SH-1161)

Location:

Devon

Salary:

GBP 30,000 per year (GBP 30K)

Description:

Reporting to: Site Quality ManagerThe Quality Assurance DepartmentThe Quality Assurance Department is responsible for monitoring the effectiveness of the Quality Management System (QMS),for example through; self inspections, investigating customer complaints, reviewing batch records, reviewing deviationinvestigations, following up on and corrective and preventative actions, reviewing and approving quality criticalchanges, reviewing and approving validation documentation. In addition the QA Department also has responsibility formanaging key elements of the QMS through the control and issue of standard operating procedures, maintenance of the sitemaster file and maintenance of the site validation master plan.The Department is also the primary contact during regulatory inspections and customer skills.Purpose of the RoleTo provide direct support to the Site Quality Manager in the management of the day to day aspects of QA Systems,providing clear direction on all aspects of Quality Management.To effectively develop and lead the QA Systems function within the QA Department to ensure both QA regulatory (EU and US)and business requirements are met at all times. To work with other departments to ensure a strong QA culture throughoutthe business.Specific Job Responsibilities Responsible for managing the self inspection programme. Responsible for the control and issue of standing operating procedures. Responsible for ensuring deviation close out and follow up on preventative actions. Responsible for maintaining the site master file. Responsible for managing the site validation master plan. Developing and implementing improved quality reporting measures. Working with the QA Systems Leader to continually improve the QMS. Managing and developing the individuals within the QA Systems Team. Providing support and advice during cross functional investigations / projects as required. Able to host customer and regulatory audits. Support and maintain Environmental Health and Safety requirements as applicable to the QA Department.Direct ReportsQA Systems Team.Relevant Skills & ExperienceEssential Knowledgeable of both EU and US pharmaceutical regulations. Proven experience of developing / maintaining and improving Quality Management Systems. Solid managerial credentials. At least 10 years experience of working within a Quality related role in the Pharmaceutical Industry. Experience of solid dose manufacture. Excellent communicator. Decisive thinker able to work within agreed timescales.Desirable Understanding of business finance. Qualified person.Relevant Professional / Education BackgroundMember of either Royal Pharmaceutical Society, Institute of Biology or Royal Society of Chemistry.Degree in Science discipline.