gcp qa.

You will join a competent and inspiring team and your main responsibilities will be:

• Ensure appropriate development, maintenance and continuous improvement of the Quality Management System (QMS)
• Support inspection readiness activities and prepare and host inspections from regulatory authorities
• Develop the annual audit program in collaboration with the Heads of Clin Ops and Ribocure Clinic
• Conduct internal and external audits to assess compliance with GCP (Good Clinical Practice) and other applicable GxP regulatory requirements
• Collaborate with cross-functional teams to ensure quality is maintained throughout the product lifecycle
• Support Ribocure Clinic staff to ensure quality and compliance at our Ribocure Clinic.
• Review and approve quality-related documentation, including policies/SOPs and related documentation, vendor evaluation, validation protocols etc
• Manage deviations, CAPAs (Corrective and Preventive Actions), and change controls to ensure timely and effective resolution
• Monitor and report on key quality metrics, driving continuous improvement initiatives.
• Collaborate with Suzhou Ribo QA department to ensure appropriate alignment, support in quality issues/CAPA assessments, knowledge sharing, joint training sessions etc
• Provide training and support to staff on GCP and current regulations, quality assurance procedures and best practices
• Stay current with industry trends and regulatory changes to ensure the company's compliance and competitive edge

To thrive and be happy in the role, we see that you bring the following experience and skill-sets:

• University degree, preferably in medical or biological science or discipline associated with clinical research
• Minimum of 5 years experience in quality assurance within the pharmaceutical or biotech industry
• Proven audit experience, including conducting GCP audits and preparing audit reports.
• Strong knowledge of regulatory requirements and industry standards (e.g., FDA, EMA, ICH).

It will be seen as a merit if you also are certified in audit training and if you can demonstrate experience and ability to drive process improvement and/or functional work.

As a co-worker you are engaged, analytical, pragmatic and solution oriented. You like collaboration and build relationships in the organization with ease. You also have good communication skills and you are humble and flexible in relation to others.

• Masters or equivalent