Corporate Quality Assurance GMP Auditor M/W
Octapharma
Wien, AT
vor 5 Tg.

Headquartered in Lachen near Zurich, Switzerland, the Octapharma Group is a leading company in the worldwide market for therapeutic human proteins.

Working at Octapharma means to have an opportunity to contribute to our common goal developing lifesaving therapies to improve patients’ lives.

Headquartered in Lachen near Zurich, Switzerland, the Octapharma Group is a leading company in the worldwide market for therapeutic human proteins.

Working at Octapharma means to have an opportunity to contribute to our common goal developing lifesaving therapies to improve patients’ lives.

We are seeking :

A motivated professional to join the corporate Quality organization as the Corporate Quality Assurance GMP Auditor . The position reports to the Head of Corporate Quality Assurance.

The role will be based in either Vienna, Austria or Stockholm, Sweden or Lingolsheim, France.

Main responsibilities :

Responsible for organizing and executing intersite cQA inspections and mock inspections at Octapharma manufacturing / packaging sites, support creation of the cQA Intersite inspection plan.

Monitor performance of cQA intersite inspections and Health Authority inspections including evaluation and escalation to relevant sites and / or functions.

Ensuring compliance with regulations and expertise in GMP. Monitoring the current regulations and guidelines (main focus on EU and FDA)

Create GMP training packages and perform trainings in GMP regulations and authority inspections

Participate in the development and harmonization work of the Pharmaceutical Quality System at Octapharma Corporation

As qualified auditor, support and execute other audits under cQA responsibility (corporate departments, subsidiaries, Distributors, suppliers and service providers.

Your Profile :

You have a medical science / life science background (university degree) focusing on Chemistry, Biochemistry, Biotechnology, Chemical Engineering or Pharmacy.

You have previous years of working experience with GMP / GDP regulations (EU and FDA) and quality related tasks within the pharmaceutical industry and 5 years as a lead auditor.

You have excellent English language skills in oral and written form (German is advantageous, additional languages are beneficial).

You have extensive knowledge about current GMP (Eudralex Volume 4 and US Code of Federal Regulations), GDP (Good Distribution Practices) and Combination Product regulations and guidelines You are willing to travel (approximately +%).

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