I have an excellent opportunity as a QA Manager working for a global, market leading healthcare company working on Innovative therapies that treat life-threatening conditions.

This is a role which sits on the senior leadership team where the individual will receive continuous growth & development opportunities within a dynamic and exciting environment.

This role will offer you

• A strategic position where you will have a high level of oversite of the quality department
• To be the point of contact for everything within QA
• The opportunity to directly contribute to site compliance driving continuous improvement strategies across a state-of-the-art sterile manufacturing facility
• To work with a passionate company who embrace change and people development to create a happy and positive working culture
• Hybrid working - 3 days onsite

You will be responsible for

• Successful implementation and management of the QMS
• Ensuring full quality compliance across the compounding facility to ensure GMP manufacturing standards are adhered to
• Supporting production in qualification measures of apparatus and validation of manufacturing processes
• Managing CAPAs, change controls, deviation management, risk assessments, root cause analysis and equipment validation
• Supporting continuous improvement activities to ensure a positive quality culture on site
• Writing, reviewing and approve SOPs and any other quality related documentation (For example equipment and process validation)

You will bring the following

• Strong experience within a QA role in a pharmaceutical GMP manufacturing environment
• Strong manufacturing and quality control experience
• You have experience in dealing with GMP audits and are familiar with method validation and method transfer projects
• BSc in a relevant Life Sciences subject
• English and German language