Qualified Person 100% (w/m/d)

Acino Latinoamericana S.A; München; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Benefits dieser Stelle

Stable and resilient pharmaceutical company

International working environment

Subsidized lunches

Complimentary coffee and tea

Attractive additional benefits

Zusammenfassung

Acino Latinoamericana S.A is looking for a Qualified Person in Munich, Germany. In this role, you will ensure GMP-compliant batch certification and release of medicinal products while maintaining regulatory compliance and quality oversight.

The ideal candidate has a university degree in Pharmacy or related fields, recognized QP status, and proven experience in the pharmaceutical industry. Great benefits include a stable working environment, an attractive salary package, and additional perks like subsidized lunches.

Qualifikationen

• Proven experience in the pharmaceutical industry and in pharmacovigilance.
• Strong understanding of regulatory requirements and quality standards.
• Strong computer literacy.

Aufgaben

• Certify that each batch of medical product meets requirements.
• Oversee batch release activities and document deviations.
• Ensure compliance with GMP standards.

Kenntnisse

Fluent in German

Fluent in English

Regulatory compliance

Quality oversight

Change management

Ausbildung

University degree in Pharmacy, Chemistry or related life sciences

Recognized QP status

Tools

Digital QMS

LIMS platforms

Jobbeschreibung

Established in 1836, Acino, part of Arcera, is a pharmaceutical company headquartered in Zurich, with a clear focus on selected markets in the Middle East, Africa, and Latin America, as well as Ukraine and Eurasian countries. With over 3,000 people across 90 countries, we deliver quality pharmaceuticals to promote affordable healthcare in these emerging markets. We also leverage our high-quality pharmaceutical manufacturing capabilities and network to supply leading companies through contract manufacturing and out-licensing.

Acino is part of Arcera, a diversified life sciences holding company, established by ADQ in Abu Dhabi in 2024 with the purpose to advance innovation in line with the Emirate’s 2030 vision for the sector and beyond.

The Position

The Role

As a Qualified Person, you ensure GMP-compliant batch certification and release of medicinal products while maintaining regulatory compliance, quality oversight, and supply chain integrity.

• 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.

Who You Are

• 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 Are Acino

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

• A position with a stable and resilient pharmaceutical company.
• An international working environment within a continuously growing organization.
• Interesting and highly diverse responsibilities that provide a strong foundation for further career development in the pharmaceutical industry.
• An attractive salary package.
• Free parking facilities.
• Complimentary coffee, tea, and fresh fruit.
• Attractive additional benefits, such as subsidized lunches and corporate benefit programs.