Job Detail

Senior QA Specialist

Job Summary:

The position holder is responsible for compliance of the Clinical Label Services department, and acts as Deputy to the CLS Quality Assurance Manager. The Senior QA Specialist is working with all the teams in the department to maintain and support the quality standard. Investigates internal incidents and customer complaints resulting from problems originating at the site Analyzes non-conformances/customer complaints and audit observations in the order of facilitate corrective action. Prepares reports, assigns responsibilities for corrective and preventative measures with responsible Managers. Is responsible for the completion of the action items agreed to within the investigation reports. Verifies that the corrective actions, taken trough CAPA remain effective. Track/trends non-conformances, complaints, audit responses, internal investigation. Is supporting internal and external audits of the departments.

Responsibilities:

• Support Team Manager in Investigation writing


• Review/approval of deviation and complaint reports


• Follow-up of CAPAs in order to ensure prompt resolution and closure


• Maintain Quality monthly Quality metrics and identify actions for negative trends


• Hosting client audits of the CLS department


• Participate in internal audits


• Support Qual Val of the equipment, rooms and process of the department


• Act as deputy for CLS QA Manager as main point of contact for CLS QA department during manager’s absence


• Participation on local and global interdepartmental projects (e.g., PPI)


• Applies Good Manufacturing Principles in all areas

Minimum Qualifications:

• Requires understanding and competent use of SOPs required by company Quality standards.


• Requires excellent organizational, planning, verbal, written and numerical skills with the ability to analyze and define solutions and manage multiple tasks to meet strict deadlines.


• Requires strong and effective communicator with the ability to effectively present information and respond to questions from groups of managers and clients.


• Fluency in German and English


• Use of Microsoft Excel.

Education / Experience:

• Requires recognized professional degree, preferably in a health related field.


• Requires 2-3 years Quality Assurance experience in a GMP environment and/or label printing experience preferred


• Able to analyze problems and define solutions


• Able to work under pressure and to support others within the team


• Excellent oral and written communication skills


• Problem solving skills