Beschreibung

In this role, you will oversee quality assurance processes, mentor team members, and ensure compliance with GMP standards. Daily activities will involve guiding investigations, supporting inspections, and driving continuous improvement initiatives.

Anforderungen

• •Bachelor's degree in a science, engineering, or pharmaceutical-related field or equivalent experience
• •Minimum 5 years in the pharmaceutical industry with Quality Assurance experience
• •Understanding of cGMP regulations and practices
• •Fluency in English and German
• •On-site presence required
• •Experience in parenteral manufacturing environments
• •Experience with C&Q and Validation oversight
• •Knowledge of US, EU, Japan and other regulations in pharmaceutical manufacturing
• •Proficiency with applicable computer systems
• •Strong oral and written communication skills
• •Interpersonal skills and teamwork ability
• •Root cause analysis and troubleshooting skills
• •Attention to detail and quality systems maintenance
• •Ability to work independently or as part of a team
• •Technical writing and communication skills
• •Computer System Quality Assurance (CSQA) experience
• •Experience with Manufacturing Execution Systems
• •Use of KNEAT or other electronic validation software

Aufgaben

• •Provide daily oversight and guidance to the process team
• •Advise on non-conformance investigations and change controls
• •Support procedures, validations, and batch disposition
• •Assist with commissioning and qualification activities
• •Mentor and coach operations personnel on quality matters
• •Monitor GMP programs and quality systems in operational areas
• •Serve as the Quality point of contact for the local process team
• •Assess and triage deviations within the process team
• •Collaborate with support groups and external partners on product issues
• •Participate in self-led inspections and support regulatory inspections
• •Initiate, review, and approve quality-related documents
• •Engage in continuous improvement projects to enhance productivity
• •Approve commissioning and validation documents for compliance
• •Network with Global Parenteral Network sites to share best practices

Tools & Technologien

Benefits