QMS Manager GDP

at  Corza Medical

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

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 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.

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.

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.

Join us today and Excel@Corza!