Description
QA Manager - CAPAOur client, a biopharmaceutical company is seeking a QA Manager to support its growing site in Germany to review and test its systems and processes for robustness.
This is a fast growing company and the successful candidate will have a chance to have an input as well as make a difference.
Key Responsibilities:
• Put together a CAPA and deviation management plan, create and implement a scalable system.
• Work closely with stakeholders in Germany and USA in the Engineering, QA and management teams.
• Review all relevant documentation for compliance with FDA and GMP requirements.
• Complete any outstanding CAPAs and Deviations.
• Train members of the team in the new CAPA and deviation process to enable handover.
• Work closely with project team to drive compliance to FDA and GMP regulations in the ongoing project work.
Requirements
• This position requires extensive experience as a QA manager, dealing with CAPA and deviations.
• Previous experience of introducing new CAPA and deviation systems or processes successfully on a number of occasions essential.
• Experience working in a small to medium size company during a scale up period desirable.
• Outstanding knowledge of GMP and FDA requirements.
• In-depth experience within the pharmaceutical industry.
• Experience working both independently and in a team-oriented, collaborative environment.
• Ability to effectively execute tasks in a high-pressure environment is crucial.
• Communications skills in both German and English is advantageous.