Manager Quality Assurance Gmp Compliance
il y a 2 semaines
In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million.
Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a...
**Your Responsibilities**:
- **Audit Leadership**:
- **Audit Planning & Preparation**: Lead customer and regulatory audit planning and preparation.
- **Audit Execution**: Host audits by leading plant tours and document reviews. Retrieve and present relevant information related to SBE processes and the Quality Management System, involving experts when needed.
- **Quality Agreements**:
- Review and approve quality agreements with customers.
- Complete and manage customer questionnaires.
- **Internal Audits**:
- Conduct internal audits to evaluate and continuously improve the Belgian site combined Management System for Quality, Environment, Health & Safety, and Energy.
- **CAPA Management**:
- Develop and manage CAPA (Corrective and Preventive Action) plans for customer, regulatory, and internal audits.
- Ensure timely responses to customers and follow up on audit reports.
- Propose robust CAPA actions and mutually agree on due dates.
- Verify the effectiveness of CAPA tasks upon closure.
- **GMP Expertise**:
- Act as the GMP expert for the Datwyler Quality Management System and ISO 9001/15378 requirements.
- Develop and deliver training materials.
- Conduct training sessions and promote quality awareness.
- Facilitate knowledge exchange by translating customer and regulatory requirements into the organization.
**Your Profile**:
- Master’s degree level of working and thinking.
- Fluent in Dutch and English.
- Excellent communication skills for interacting with external stakeholders (suppliers and customers), internal stakeholders (operations), and the global organization (e.g., global process engineers, global Quality, other Datwyler sites).
- Quality Assurance Experience:
- Strong understanding of quality principles and quality management systems with relevant QA experience in a GMP environment.
- Familiarity with ISO 9001, ISO 15378, USP, EP, and Annex 1.
- Understanding of production processes, including their qualification, risks, related policies, procedures, new products and processes, and customer expectations.
- Ability to manage work independently and collaborate effectively across teams.
**Be yourself at Datwyler**
We are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas.
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