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Vacancy Name

QMS Manager GDP

Location of Work

Linz, Austria

Employment Type

Full Time Employee

Job Description

Our mission

We are here to support you every step of the way.

Our brand promise

• Remarkable service

• Trusted performance

• Outstanding value

No matter the surgical specialty, we deliver quality products for all markets.

Our people promise

Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.

Job Purpose Summary

Ideally, you have a proven ability to collaborate effectively with cross-functional teams and ensure high standards across operations.

• 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.

• 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

• 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).

• 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.

• 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.

Join us today and Excel@Corza!

Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics.