Qualified Person 100% (w/m/d)

Acino International AG; München; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Benefits dieser Stelle

International working environment

Flexible working hours

Attractive salary

Motivated, agile team

Zusammenfassung

Acino International AG in Munich is seeking a Qualified Person to oversee compliance with quality standards in the pharmaceutical industry. The ideal candidate will have a university degree in Pharmacy or related fields and QP status.

This role involves certifying medical products, managing batch release activities, and ensuring third-party compliance with regulations. The company offers a flexible working environment, attractive salary, and international exposure.

Qualifikationen

• Proven experience in pharmaceutical industry and in pharmacovigilance (GVP).
• Strong understanding of regulatory requirements and quality standards.

Aufgaben

• Certify that each batch of medical product is manufactured and tested in accordance with Marketing Authorization requirements.
• Oversee batch release activities, ensuring all deviations and CAPAs are properly investigated and documented.
• Maintain oversight of the supply chain to prevent distribution of non-compliant or falsified medicines.
• Ensure compliance of third-party manufacturers and suppliers with GMP standards.
• Certify and release batches of medicinal products.

Kenntnisse

Fluent in German

Fluent in English

Strong computer literacy

Ability to drive change

Excellent communication skills

Ausbildung

University degree in Pharmacy, Chemistry or related life sciences

Recognized QP status and valid authorization from relevant health authorities

Tools

Digital QMS

LIMS platforms

Jobbeschreibung

Acino AG, based in Munich, is part of the Acino Group, a Swiss pharmaceutical company and a leader in advanced drug delivery technologies with its headquarters in Zurich.

Acino out-licenses its own products and manufactures third party products mainly for the European market. In its commercial operations, Acino has a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America. We operate in some of the most dynamic countries of the world. We value courage, commitment, trust, and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.

We are constantly expanding our market position with a future-oriented international business strategy. Therefore, we are looking for a dedicated and motivated person to strengthen our team in Munich, Germany.

Qualified Person 100% (w/m/d)

Major Accountabilities

• Certify that each batch of medical product is manufactured and tested in accordance with Marketing Authorization requirements, GMP and applicable regulations.
• Oversee batch release activities, ensuring all deviations and CAPAs are properly investigated and documented
• Maintain oversight of the supply chain to prevent distribution of non-compliant or falsified medicines.
• Ensure compliance of third-party manufacturers and suppliers with GMP standards.
• Ensure batch certification is performed in accordance with GMP requirements and ethical standards. Maintain up-to-date knowledge of legal requirements and technical standards
• Certify and release batches of medicinal products
• Contribute in a team of quality professionals

Your Profile

• University degree in Pharmacy, Chemistry or related life sciences
• Recognized QP status and valid authorization from relevant health authorities.
• Proven experience in pharmaceutical industry and in pharmacovigilance (GVP)
• Fluent in German and English, with excellent written and verbal communication skills
• Strong understanding of regulatory requirements and quality standards
• Strong computer literacy and familiarity with digital QMS and LIMS platforms.
• Ability to drive change and foster a culture of quality and compliance.

We offer a very attractive working environment within a highly motivated team with excellent working conditions. You can expect the following benefits:

• An international working environment in a constantly growing company
• A quality and customer-oriented environment
• A motivated, agile and service-oriented teamInteresting and highly diversified tasks that provide a broad basis for your future career in the pharmaceutical industry
• Attractive salary
• Flexible working hours (possibility of home office)

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If you are interested in this role we are looking forward to hearing from you.