Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers headed up by a centralised leadership team.
With a focus on tailormade and scalable solutions, well adapt our delivery style, communications and operations to suit the demands of your project, helping you achieve your clinical and commercial objectives. Because our goal is the same as yours; to improve patients lives.
Main Duties and Responsibilities:
We are looking for a Quality Assurance Officer to join our Quality Assurance department.
You will work with colleagues across all functional areas operational and non-operational to deliver Simbec-Orion's Clinical Development services to the highest quality standards for our clients, in compliance with all applicable regulations and guidelines.
You will also contribute to maintaining and improving the Quality Management System as new regulatory requirements evolve.
Previousexperience working in a QA Auditor role within a regulatory pharmaceuticalorganisation
Experience ofauditing to GCP and GMP quality standards
Experience of MSOffice
Excellent communication skills; with colleagues at all levels when discussing and relating findings (written and orally).
Excellentorganisation and time management skills
Ability toanalyse and resolve problems in a logical way with root cause analyses of non-complianceand CAPA
Previous experienceof working within a fast-paced environment with the ability to deal effectivelywith changing priorities
BSc in life sciences
Experience of performing audits of facilities, systems or subcontractors
Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.