CSV Manager

Job content

Elevate Your Career in Computerized Systems Validation (CSV)

Your Responsibilities:

Are you passionate about ensuring data integrity, electronic records management, and regulatory compliance? Join our Quality Assurance (QA) team in Rheinfelden as an ERP Key User and Core Team Member, and play a crucial role in maintaining the highest quality standards.

Your responsibilities include:

• Data Integrity and Records Management: Lead QA-related tasks to ensure data integrity and reliable electronic records management.
• Software and IT Compliance: Ensure compliance with software and IT standards, including Excel spreadsheet validation and computerized system validation.
• QA Support for IT Changes and Serialisation/TES: Provide QA support for IT changes and Serialisation/TES initiatives, ensuring adherence to quality standards.
• Computerized System Validation: Review and approve computerized system validations, showcasing your expertise in this critical area.
• CSV-Related Projects: Represent QA in CSV-related projects, contributing your knowledge and insights to ensure success.
• Supervision and Support: Oversee QA-relevant issues and processes, with a focus on GxP-related computerized systems, IT, ERP, and Serialisation/TES. Offer support as needed.
• Supplier and Customer Relations: Coordinate quality-related relations with suppliers and customers, addressing deviations, CAPA, and changes.
• Document Management: Manage and maintain quality documents, such as SOPs, to uphold our high standards.
• Batch Documentation and Shipment Release: Review batch documentation and perform shipment release to ensure product quality.
• Audits: Complete internal and external audits to verify compliance and quality standards.

Who You Are:

• Educational Background: Hold a minimum bachelor’s degree in a life science-related discipline.
• CSV Expertise: Possess a minimum of 5 years’ experience in Computerized Systems Validation (CSV).
• Regulatory Knowledge: Demonstrate excellent knowledge and understanding of regulatory requirements, including GMP (including 21 CFR Part 11 and EU GMP Guide Annex 11) and GAMP5 guidelines.
• QA Compliance: Have a good knowledge of QA compliance standards.
• Language Skills: Be fluent in both English and German, both written and spoken.
• Team Player: Exhibit flexibility and structured teamwork, even in a fast-paced, rapidly changing environment. Approach challenges with a problem-solving mindset.
• Pressure Handling: Capably work under pressure and effectively prioritize tasks to meet deadlines.
• Willingness to Travel: Be open to occasional travel (up to 5% of your time).
• Remote Work: Enjoy the flexibility of remote work, with the opportunity to work from home up to 40% of the time.

Why Join?

• Fast-Growing Mid-Sized Pharma Company: Be part of our exciting journey as we expand and make a significant impact in the industry.
• Working with Different Clients and Partners Worldwide: Collaborate with a wide range of clients and partners from around the world, experiencing global diversity.
• Constant Improvement and Training Offered: We are committed to your growth and development, offering continuous improvement and training opportunities.
• Well-Established and Financially Solid Company: Enjoy the stability of working for a well-established and financially solid company.
• Positive and Family-Type Corporate Culture: Join a corporate culture that is positive and feels like a family, valuing collaboration and mutual support.
• Good Retention Rate of Staff: Be part of a company that recognizes and rewards its talented staff, boasting a high retention rate.
• Remote Working: 40% HO: Improve your work-life balance with the flexibility of remote work, with the opportunity to work from home 2/3 days per week.
• Collaborate with Healthcare Professionals and GI Experts: Contribute to improving care for people with GI disease by collaborating with healthcare professionals and GI experts, developing and marketing impactful GI medicines.
• Gain In-Depth Knowledge of Gastroenterologists and Hepatologists Innovative Drugs: Deepen your understanding of gastroenterology and hepatology, gaining insights into innovative drugs and therapies.
• Leading International Specialty Pharma Company: Join a leading international specialty pharma company with multiple roles and vacancies available, with the possibility to work worldwide based on your expertise.
• Established Presence Worldwide: Join our network of gastroenterology-focused partners across Europe and the globe as we market our products in around 65 countries.

If you are a dedicated professional who meets these qualifications and is passionate about ensuring the highest quality standards, we invite you to apply for this exciting opportunity.

Join and become a key player in our pursuit of excellence in Quality Assurance.