Quality Assurance Manager
vor 4 Wochen
SOL Deutschland GmbH, a leading industrial gases group, is seeking a highly skilled Quality Assurance Manager to join their team in Frankfurt. As a key member of the organization, you will be responsible for ensuring the highest standards of quality and compliance across the company.
Key Responsibilities:- Supervise quality control and assurance activities in accordance with ISO 9001, 13485, 22000, and 50001 standards, as well as GMP and GDP regulations.
- Manage the release of batches of medicinal and medical device gases, working closely with the team of designated Qualified Persons.
- Act as the primary point of contact for customer auditors, ensuring the site meets the required standards.
- Maintain all authorizations and certifications, coordinating audits and inspections, and fostering relationships with auditors and inspectors.
- Perform internal and supplier audits, identifying areas for improvement and implementing corrective actions.
- Support internal and external training programs, ensuring employees have the necessary skills and knowledge to meet quality standards.
- Develop and implement the Validation Master Plan for the new plant, scheduled to start in 2025.
- Upgrade the existing quality management system to align with the evolving plant requirements.
- Manage complaints and non-conformities, ensuring prompt resolution and continuous improvement.
- Proven experience in quality assurance, preferably in the pharmaceutical industry, with a strong understanding of GMP and GDP regulations.
- Excellent communication and interpersonal skills, with the ability to work effectively with colleagues from diverse backgrounds.
- Strong analytical and problem-solving skills, with the ability to identify and implement process improvements.
- Proficiency in MS Office and Google Workspace, with the ability to adapt to various commercial and internal IT tools.
- A dynamic and challenging work environment, with opportunities for professional growth and development.
- A competitive compensation package, including a company pension plan based on the chemical industry.
- A 37.5-hour workweek, with 30 days of vacation, and a collegial, team-oriented working atmosphere.
- Long-term professional prospects in a future-proof industry, with opportunities for advancement and leadership development.
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