QMS Manager GDP (m/w/d)

At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience. We are here to support you every step of the way.

What we value

* Customer First - We deliver extraordinary experiences.
* Accountability - We do what we say.
* Integrity - We do what is right.
* Inspired - We love what we do.
* One Global Team - We before me, always.

QMS Manager GDP (m/w/d)

Job Purpose Summary

We are looking for an experienced QMS Manager GDP professional specializing in Good Distribution Practice (GDP) with a strong focus on maintaining and improving quality systems. In the role you will be also driving compliance, supporting supply chain teams, and leading process improvements. Ideally, you have a proven ability to collaborate effectively with cross-functional teams and ensure high standards across operations.

What you will do

* overseeing and managing all quality assurance aspects of good distribution practice (GDP)
* Responsible for GDP quality management system (QMS) / Maintenance and further development of the GDP QMS with considering requirements for medicines, combination products, medical device
* Deputy function of Responsible person
* vendors/suppliers qualification of GDP contract partners
* Preparation of quality agreements for GDP contract partners
* Assurance of GDP customer qualification
* QA Support for supply chain team
* QA responsibility for GDP transport validation
* QA responsibility for GDP Quality Risk assessment (QMR)
* Preparing GDP documentation
* Responsible for GDP questionnaires / GDP parts in questionnaires
* Conducting internal and external audits
* Support during audits and inspections by authorities
* Lead and/or participate in projects in the areas of innovation and efficiency improvement
* Support Guideline compliance
* Participation in the further development and improvement of quality processes
* Strong cooperation with production site organization in Biosurgery division

What you will need

* Completed scientific/technical education in the pharmaceutical, or pharmaceutical-related field (chemistry, biology, biotechnology).
* Minimum of 5 years of experience in pharmaceutical QMS, including knowledge of regulatory requirements and guidelines, particularly the Good Distribution Practices (GDP) guidelines.
* Strong understanding of pharmaceutical quality management processes and systems.
* Excellent organizational and project management skills.
* Experience in performing supplier audits
* High level of initiative, high quality awareness and effective communication skills.
* Excellent command of English and German (written and oral).

What we offer

* We consider applicants seeking part-time employment with a minimum of 25 hours per week
* Collaboration in an international, motivated, and dedicated team that will provide the best possible support during your onboarding.
* The opportunity to work independently and responsibly, and to actively shape processes.
* A modern work environment with flexible working hours and the option to work from home.
* A gross monthly salary on a full-time basis starting from EUR 5,000.00, with a willingness to pay more depending on qualifications.
* Benefits: meal allowance, company pension plan, employee referral program, discounted gym membership, and more.

smart bewerben

Corza Medical Distribution GmbH, Austria Branch
Sankt - Peter - Straße 25, 4020 Linz
Alexandra.logigan@corza.com
www.corza.com