\\n Supply Chain Manager

ERP Key User and Core Team Member (QA Department)

Basel \\xe2\\x80\\x93 Permanent

Are you ready to take the helm in ensuring data integrity and electronic records management within a fast-growing mid-sized pharmaceutical company? If you have a passion for quality assurance and a strong background in Computerised Systems Validation (CSV), we want to hear from you!

About Us: We are a well-established and financially solid pharmaceutical company with a strong presence in Europe and the rest of the world. At our core, we are committed to improving the care for people with GI disease. We collaborate with healthcare professionals and GI experts to develop and market innovative GI medicines, gaining in-depth knowledge of gastroenterologists and hepatologists\\xe2\\x80\\x99 needs. As a leading international specialty pharma company, we offer multiple roles and vacancies, providing you with the opportunity to work worldwide according to your expertise.

The Role: As an ERP Key User and Core Team Member in our QA Department, you will play a pivotal role in maintaining the highest quality standards across our organisation. Here\\xe2\\x80\\x99s what you\\xe2\\x80\\x99ll be responsible for:

Data Integrity and Records Management: Ensure QA-related tasks related to data integrity and electronic records management are meticulously executed.

Software and IT Compliance: Maintain software and IT compliance, including Excel spreadsheet validation, computerised system validation, and supplier (re)qualification for computerised systems and services.

IT Changes and Serialisation/TES: Take charge of QA-related tasks for IT changes and Serialisation/TES.

Computerised System Validation: Review and approve computerised system validation processes, ensuring they meet regulatory requirements.

CSV-related Projects: Represent QA in CSV-related projects to support the company\\xe2\\x80\\x99s compliance initiatives.

Quality Management: Supervise QA-relevant issues and processes, with a focus on GxP-related computerised systems, IT, ERP, and Serialisation/TES.

Supplier and Customer Relations: Coordinate quality-related relationships with suppliers and customers, addressing deviations, CAPA, and changes as needed.

Document Management: Manage and maintain the revision and compilation of quality documents, such as SOPs.

Audits: Participate in internal and external audits to uphold our commitment to quality standards.

Who You Are: To excel in this role, you should possess the following qualifications and attributes:

Educational Background: Minimum bachelor\\xe2\\x80\\x99s degree in a life science-related discipline.

CSV Expertise: At least 5 years of experience in Computerised Systems Validation (CSV).

Regulatory Knowledge: Excellent knowledge of regulatory requirements, including GMP (including 21 CFR Part 11 and EU GMP Guide Annex 11) and GAMP5 guidelines.

QA Compliance: Good knowledge of QA Compliance practices.

Language Skills: Fluency in English and German, both written and spoken.

Team Player: A flexible and structured team player who can thrive in a fast-paced, rapidly changing environment with a problem-solving approach.

Pressure Handling: Ability to work under pressure and prioritise tasks effectively.

Travel: Willingness to travel up to 5% of the time.

Remote Working: Enjoy the flexibility of remote working with the option to work from home 2-3 days per week, contributing to an improved work-life balance.

Why Join Us:

Career Growth: We are a fast-growing company with opportunities for career advancement and constant improvement through training.

Positive Culture: We foster a positive, family-like corporate culture, resulting in a good retention rate among our staff.

Global Impact: Contribute to our mission of improving care for people with GI disease by collaborating with healthcare professionals and GI experts worldwide.

International Exposure: As a leading international specialty pharma company, we offer roles that allow you to work globally according to your expertise.

Market Presence: Join a company with an established presence in Europe and around the world, marketing our own products and in-licensed products in approximately 65 countries.

If you\\xe2\\x80\\x99re ready to make a meaningful impact in the pharmaceutical industry while enjoying a flexible work environment, apply now to join our team as an ERP Key User and Core Team Member in our QA Department.\\n \\n \\n \\n \\n \\n

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