Senior Quality Compliance Officer

Senior Quality Compliance Officer

Almac Group

Craigavon, United Kingdom

The Role

Almac Sciences are recruiting for a talented Senior Quality Compliance Officer to join our team. The post holder will support the management and compliance of the Quality Management System within the Craigavon site. They will actively participate in, and promote, Quality Compliance activities and GMP improvement initiatives throughout Almac Sciences.

Responsibilities include, but are not limited to:

• Lead quality investigations assigned to you and ensure effective CAPA actions are implemented;
• Lead Quality Risk assessments, as required, ensuring all risks identified are appropriately mitigated;
• Support/host customer audits for manufacturing services and support Regulatory audits on Craigavon site, as required;
• Authorise Change Controls and Unplanned Deviations, as the representative of the QA Department, where appropriate;
• Ensure written instructions are available for all relevant GMP activities. This may involve writing SOPs.

Key Requirements

• Degree level (or equivalent) qualification in a Life Science related discipline;
• Experience working in a quality or laboratory environment operating to GMP principles or recognised quality system (e.g. ISO);
• Experience of perform internal audits;
• Experience of generation and or review of Quality related documents.

Desirable Requirements

• Experience working in a Quality Assurance role supporting the manufacture of APIs or Drug products;
• Experience of Change Control within a GMP environment;
• Experience performing investigations into quality issues and identifying CAPA actions.