Quality Assurance Officer

Overview

Want a 3D Career? Join Norgine. At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community. We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits. Bring everything about yourself that you''re proud of, whether that''s your passion for making a difference, focus on others'' well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community. In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people''s wellness as much as you do. Because at Norgine, we transform lives with innovative healthcare solutions. We have an exciting opportunity for a Quality Assurance Officer to join Norgine. If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.Requirements

To perform batch review, either as a delegated duty from the QP or as a QP, in support of the certification processTo assist and facilitate the identification, assessment, investigation and reporting of quality incidentsTo provide advice and training on all quality related matters including but not limited to GMP, ISO standards, validation, and auditingTo maintain an overview of quality compliance through the effective use of key performance indicatorsTo review and approve quality related documents for the siteTo support and facilitate internal and external inspectionsReporting Quality related KPI''s to the site and globallyLead, participate and support projects to enable continuous improvementsPreparation of quality related documentation, including but not limited to the SMF, GMP training, monthly and quarterly reportsMaintain the manufacturing site licencesKey responsibilities and accountability

Review batch documentation and any associated deviations to ensure satisfactorily completed prior to batch certification by the QP or responsible person for Medical DevicesMaintain, support and improve the QMS employed within Norgine and to promote continuous improvements, whilst maintaining compliance with regulations and standards for medicinal product and medical devicesTo manage and perform internal self-inspections and external audits, including vendors and suppliers, for commercial and investigational medicinal productsTo support the QP in the execution of their legal and routine dutiesMaintain key quality documents, including, but not limited to, the site master file, inspection evidence files and Quality related SOPsCoordinate and perform investigations related to product quality complaints and liaise with market QMRsSupply information for, coordinate execution and review of Product Quality Review processTo support the ONE Norgine model particularly with regards the Global QualitySupporting delivery of site quality objectives and support of Global Quality objectivesCreation of Quality Agreements for commercial partnersRelationships

Maintains excellent working relationships with all departments across Hengoed site. Liaise with other manufacturing sites within Norgine and through the External Network Structure.Skills and Knowledge

A degree or equivalent in a scientific discipline is preferred with experience in a Quality environment in the pharmaceutical industryStrong Communication Skills Are EssentialThe ability to introduce, co-ordinate, complete and report on projectsA high level of self-motivation is necessaryAttention to detailAble to rationally persuadeInfluencing skillsAbility to perform audits, internally and externallyBenefits

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.Additional Details

Seniority level: Entry levelEmployment type: Full-timeJob function: Quality AssuranceIndustries: Non-profit Organizations and Primary and Secondary EducationReferrals increase your chances of interviewing at Norgine. Get notified about new Quality Assurance Officer jobs in Hengoed, England, United ..... full job details .....