Description Key Responsibilities:- Administer and develop the following elements of the Pharmaceutical Quality System: Product Quality Reviews Technical/Quality Agreements Self-Inspection Customer Complaints Second-level Batch Record reviews Creation of Certificates of Conformity and Certificates of Analysis (including regulatory requests) Ordering of stationery and switchboard cover Preparation of documentation for EU release Validation / documentation store activities including pallet archiving / retrieving for all departments Update SOPs / FORMs, create new systems on a continuous improvement basis Collation of data for preparation of PQRs Document Control; the issuance and reconciliation of controlled documentation Ensure there are no overdue Quality System records that are attributable to your name. Support, as required, activities that relate to client audits and regulatory inspections. Keep abreast of and maintain systems in line with changing regulations and industry expectations. Constructively challenge deficiencies and inefficiencies. Identify and participate in continuous improvement initiatives within Quality. Qualifications ESSENTIAL QUALIFICATION: None RELEVANT/ESSENTIAL EXPERIENCE:- ‐An appreciation of GMP and GDP, such as the MHRA’s Orange and Green Guides, EU’s Eudralex Volume 4, USA’s CFRs 210 and 211, ISO, ICH, and PIC/S (desirable) ‐Administering elements of a Pharmaceutical Quality Management System (desirable) ‐High Level of Attention to detail ‐Excellent IT skills, proficient in Word / Excel ‐Organised and a good team player