Quality Officer - German speaker

About Qualifyze

Founded in September 2017, Qualifyze is the fastest growing third-party audit provider in the world. Qualifyze’s success builds on a one-of-a-kind digital audit platform that connects the most important stakeholders of the pharmaceutical industry: manufacturers, suppliers and auditors. With Qualifyze, customers can solve their audit demands 100% digitally and benefit from instant pricing and high quality audit reports. Our goal is to grow into the most used audit marketplace in the world, while making supply chains more transparent and efficient. Therefore we are constantly looking for people to join our dynamic and multicultural team of well-educated and motivated professionals. If you want to be part of our success story, we would love to hear from you.

MAIN RESPONSIBILITIES

At Qualifyze, each person has the ability to make a difference. We all have a mission-critical role in transforming supplier qualification in pharma. With the support of other teams, the goal of the Quality Officer is to ensure that our services meet all the requirements and they are high-quality before they reach the consumers.

As Quality Officer, you will:

• Support the auditor during audit preparation (gathering information from auditees and customers, preparing the audit agenda, discussing the audit best approach and potential critical points, etc.) for DACH region
• Review audit reports in German to identify deviations from quality standards and to ensure the audit has been conducted in compliance with legal standards and meeting customers' expectations.
• Conduct and/or participate in GxP audits (API, excipients, and packaging materials manufacturers and distributors, etc.).
• Follow-up on CAPA derived from audits.
• Participate in the development of Qualifyze common voice (templates, internal guidance, internal training sessions, auditor webinars, and forums).

WHAT YOU CAN EXPECT FROM US

• Be part of a hyper-growth startup redefining how supplier qualification in pharma is done.
• Professional development through direct contact with GxP audits and top-level auditors around the world.
• Dynamic team who attaches great importance to reliability, stakeholder-oriented thinking, creativity, pragmatism, and open communication.
• Modern co-working space in the heart of Barcelona.
• Flexible working hours and the ability to work from home when it suits you.
• Innovative company with a strong emphasis on a positive intercultural environment and diversity.
• An international working environment characterized by flat hierarchies, a great company spirit, and open feedback.
• Steep learning curve that is supported by training and development sessions.
• Other benefits: flexible working hours, regular company events, travel stipend, additional equipment, etc.

• Academic background in life sciences (pharmacy, chemistry, biology, biotechnology, biomedicine, etc.)
• At least 2 years of experience in the pharmaceutical industry or in GxP audit service providers
• Knowledge of GxP standards/guidance (GMP, GDP, ISO15378, ISO 13485, Pharmacovigilance “GVP”).
• German language proficiency at a business level
• English language proficiency at a business level.
• Strong spoken and written communication skills.
• Strong tech-savvy skills.
• You place high value on attention to detail.
• You are empowered to try out new things and take ownership.