Job Description
My client is seeking an experienced Quality Assurance professional with experience in the Pharmaceutical Sector to provide support to the Qualified Person (QP) for R&D supplies shipped through the EU and as well to provide QA support to Clinical Supply Logistics amongst other duties. The Role: Compiles Qualified Person batch release dossiers Supports Packaging & Labelling activities performed at EUWH. Provides Quality Assurance support in the Use Date Extension process. Provides Quality Assurance support (GMP/GDP guidance and training) for CSO Regional Logistics. Support in a timely manner, the investigations of non-conformances and quality incidents. Resolves and documents into Quality Management System deviations or problems pertaining to the review of documents. Conducts appropriate follow-up as required. Tracks deviation, investigations and CAPAs. Authors ISR related Quality agreements, keeps agreements current and manages updates required. Prepares release dossiers for ISRs Prepares and reviews procedural documents as requested by supervisor. Support preparation of training materials. Contribute to improving and maintaining CSCQ QMS Prepare and approve supply chain flow maps, and product specification files. Authoring, review, and approval of QA-related procedures Supporting generation of/updates existing Quality Agreements. Experience & Qualifications The successful candidate will hold a BSc in Science or related discipline, with relevant QA or related experience in a Pharmaceutical environment. A clear understanding of cGMP requirements for manufacturing and/or systems and compliance. The QA specialist will be required to work on his/her own initiative in addition to working as part of a team. The candidate must be able to work across a team matrix in order to meet accelerated timelines. Excellent communication & presentation skills are essential. The successful candidate must demonstrate excellent time management & organisational skills along with a proven ability to multi-task. The Next Step for you: Should this position be of interest to you please forward your CV to Barry O'Mahony from Next Generation Recruitment or alternatively call on the main line on Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions. Applications are in strict confidence. Next Generation will never share your data outside of our organisation without your prior written consent. Please read our Data Protection Policy on our website. Skills: QA Specialist Pharma Quality Assurance