Description

Our client is a Swiss-based CDMO focused on sterile ophthalmic and injectable products. They offer end-to-end support from formulation through to commercial-scale manufacturing, all under stringent GMP conditions.
To strengthen their team, they are looking for a new Manager QA Deviations.
Responsibilities

• Classification and assessment of deviations and coordination of activities related to the processing of deviations, including ensuring the timely completion of investigations

• Support in root cause analysis and definition of corrective and preventive measures

• Ensuring compliance with regulatory requirements

• Evaluation of trends and collection of KPIs

• Support with regulatory inspections and audits

Requirements

• Completed scientific degree or university degree (chemistry, pharmacy, biology, physics)

• Good understanding of GMP requirements and at least 2 years of relevant experience in a GMP environment

• Very good knowledge of German and English

• Proficient MS Office skills

• Assertiveness and good communication skills

• Knowledge of statistics is an advantage