Description

You will ensure GMP compliance and inspection readiness by providing expert quality oversight for device assembly and packaging, while mentoring the team and driving continuous improvement.

Requirements

• •Degree in science, engineering, pharmaceutical-related field or equivalent
• •Five years pharmaceutical Quality Assurance experience
• •Understanding of cGMP regulations and compliance
• •Fluency in English and German
• •On-site presence
• •Experience in pharmaceutical manufacturing environments
• •Experience with C&Q and Validation oversight
• •Knowledge of US, EU, Japan regulations
• •Proficiency with applicable computer systems
• •Strong oral and written communication skills
• •Interpersonal and teamwork skills
• •Root cause analysis and troubleshooting skills
• •Attention to detail and quality maintenance
• •Ability to work independently or together
• •Technical writing and communication skills
• •Computer System Quality Assurance experience
• •Experience with Manufacturing Execution Systems
• •Use of KNEAT or electronic validation software

Tasks

• •Maintain a safe work environment and lead safety initiatives
• •Mentor and coach personnel on quality matters
• •Monitor GMP programs and quality systems in operational areas
• •Act as the Quality point of contact for the process team
• •Assess and triage deviations within the local process team
• •Resolve product issues with support groups and external partners
• •Support regulatory inspections and participate in self-led audits
• •Review and approve quality documents and technical studies
• •Participate in continuous improvement projects to boost productivity
• •Approve validation documents for computer systems and equipment
• •Benchmark best practices with Global Parenteral Network sites
• •Provide guidance on non-conformance investigations and change controls

Tools & Technologies

Benefits