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Quality Assurance Leader

vor 4 Wochen

Wien, Österreich GE Healthcare Vollzeit

**Job Description Summary**: In this key Quality role for our Austrian business you will develop and maintain Quality systems, rules, and processes to ensure the fulfillment of internal and external quality requirements related to distribution and logistics processes for our time critical pharmaceutical products. You will proactively ensure that projects and products are capable and will meet specified standards. With your in-depth understanding of key business drivers you will use this understanding to accomplish your missions. You understand the interdependencies between the different teams globally to achieve the common objectives in Quality.

This role is hybrid, with some attendance at the office in Vienna and the warehouse in Großebersdorf.

This role is a Fixed Term Contract for 18 months, with the option to renew for a further 6 months.

At GE HealthCare, our machines, our software, our solutions, our services, and our people make a genuine difference to medical professionals and patients all over the world. That’s because we never lose sight of what healthcare really needs—the human touch.

In close cooperation with our global distribution sites you will hold the QA responsibility as Delegate Responsible Person (RP) for the wholesale distribution activities of GE Healthcare Austria, under a Wholesale Dealer’s Authorisation.

**Key Responsibilities include**:
Quality Management System - Good Distribution Practices (GDP)
- You will be working with the QA Distribution QMS, to develop, implement and maintain procedures relating to the wholesale distribution activities of distributed products
- You hold the RP responsibilities for warehouse storage and outbound deliveries of products to end customers in Austria
- You manage outsourced activities - 3PL, local carriers, including supplier qualification, audits and Quality and Technical Agreements
- You are responsible for the Quality Risk Management of the wholesale distribution operation and oversee the customer qualification process
- You assist in developing and delivering training for functions supporting GDP activities
- You liaise with regulatory authorities regarding activities related to the wholesale distribution activities of distributed products under the WDA
- You hold the RP responsibilities for returns (final disposition of returned, rejected, recalled or falsified products), product recalls where required and are the Point of Contact for Customer Complaints related to distribution
- You will perform Self-inspection and Internal Audit and host Quality System Audits (internal and external)
- You are responsible for Deviations, Investigations, Corrective Actions relating to the wholesale distribution operation and QA support for other GDP activities
- You will constantly monitor and review our Quality System for effectiveness and implementation of continuous improvement programs

**Your Profile**:

- You hold a University degree in pharmacy, human sciences, dentistry or veterinary medicine, chemistry, biology or a related discipline
- You are eligible to be designated a Responsible Person on a Wholesale Dealer’s Authorisation in Germany and were ideally prior designated as a Responsible Person on a Wholesale Dealer’s Authorisation
- You bring a proven relevant professional experience as a Responsible Person in the pharmaceutical industry, preferably in a Distribution or Manufacturing environment
- You bring fluent Language skills in English and German in written and spoken
- You bring the experience in dealing with competent authorities
- You bring strong problem solving skills and an experience in auditing (as auditor and auditee)
- Your high degree of self-motivation and self-responsibility together with strong influencing abilities help you to work with cross functional and a multinational team

**About GE HealthCare**

**Rewards**

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

**Inclusion and Diversity**

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare - Create a world where healthcare has no limits

LI-KRONE

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**Additional Information**:
**Relocation Assistance Provided**:No

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