Provides support to Qualified Person (QP) for R&D supplies shipped through EU Central Warehouse (EUWH) and provides QA support to Clinical Supply Logistics.
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 candidate should also be open to travel in support of their role, where necessary.
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.
Key Responsibilities and Major Duties
* 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.
* Adherence to clients core behaviours
