Documentation Specialist Nasal Spray

Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.

What the job looks like

Each day you'll enjoy a variety of challenges, such as:

• Revision of the GMP documentation of the Nasal Spray production department: Master Batch Record, Standard Operating Procedures, Rework Reports and Protocols.
• Management of investigations following Deviations or Complaints for the Nasal Spray production department.
• Management of CAPA, Change Control, and associated operational activities for the Nasal Spray production department.
• Management of training for Operational staff in the department.
• Review of Executed Batch Records.
• Monitoring of production processes and data analysis.
• Daily collaboration and support with department Supervisors.
• Participation in audits conducted by clients and health authorities (AIFA and FDA) and internal GMP audits.

What you'll bring to the table

To make the most of this role and truly thrive, you should have:

• Excellent knowledge of GMP regulations.
• Previous experience in the Creation / Management / Review of GMP documentation (Standard Operating Procedures, Change Control, CAPA, Batch record review).
• Previous experience in managing investigations for Deviations.
• Degree in scientific subjects (Chemistry, Pharmacy, Biotechnology, CTF and similar).
• Excellent knowledge of the English language.

Grünenthal offers equal employment opportunities. Recruitment will take place without distinction with regard to religion, gender, sexual orientation, age, origin, disability or other relevant categories.