Regulatory Compliance Officer - GxP

CW Recruitment Specialist
£Exc + bens
28 Sep 2016
28 Oct 2016
Contract Type
CWRS invites applications on behalf of their biopharmaceutical client where an exciting new, permanent opportunity now exists for a Regulatory Compliance Officer based in Nottingham. Job Purpose: Key duties include: Ability to travel, as required to all facilities within the QA Group. Performing internal audits as per internal audit schedule. Reporting findings to appropriate personnel and monitoring progression of actions to ensure prompt completion through the CAPA system Provide support to all members of the QA group where required. Ensure familiarity with current Regulations and Standards as applicable. Ensure continual improvement via the review of internal processes and the implementation of measures where appropriate. Aid in the production, distribution and review of all Controlled Documentation within the Quality Management System. Aid in the maintenance of other key quality management system processes, and the in the development and maintenance of Q-Pulse (Electronic Quality Management System). Performing end-of-study audits for GCP compliance. Aid in hosting Client audits or Regulatory inspections and the development of responses to subsequent reports. Administer and ensure the ongoing security, integrity and regulatory compliance of the QMS archive. Ensure all regulatory documentation, materials and quality records are appropriately indexed and documented, and stored appropriately within the archive. The ideal candidate will be/have: · Previous experience in a similar role working to GxP guidelines · Ideally from a pharmaceutical background in manufacture or testing · Knowledge of QPulse is very desirable · Able/willing to travel between sites This job was originally posted as