QA Compliance Manager

at  Thermo Fisher Scientific

Education and Qualifications:

• Qualification and eligibility as a Responsible Person in Switzerland
• Pharmaceutical degree, or other natural sciences degree
• A minimum of 2 years pharmaceutical Quality experience, or other experience as recognized by Swissmedic
• Fluent in English and German
• Broad knowledge of Swiss and EU GxP requirements
• Solid understanding of Excel, Word, and quality management software (e.g., Trackwise)
• Excellent social skills: ability to build and maintain relationships with internal and external customers; highly Functioning team leader and team member in a dynamic business environment
• Leadership skills: Proven track record to empower and encourage others, drive meaningful change, and negotiate mutually beneficial outcomes.
• Strong social skills both written and verbal
• Problem solving ability

Key Duties and Responsibilities:

• Ensure site compliance with GMP, GDP and internal procedures.
• Lead the client facing audit host team and ensure that client audits are led effectively
• Responsibile for the execution of the annual internal audit schedule
• Perform audits as internal auditor
• Delegate for Duties of the Responsible Person (Fachtechnisch verantwortliche Person) according to Swiss Medicinal Products Licensing Ordinance (Arzneimittel-Bewilligungsverordnung), permanently or in case of absence
• Release decision for medicinal products (technical green light) independently from the management
• Responsible for communication with the regulatory authority Swissmedic
• Perform training for areas of expertise, e.g. GMP
• Participate on Global Quality projects
• Support PPI Projects for continuous improvement
• Demonstrate and promote the company vision according to the 4i values.

Education and Qualifications:

• Qualification and eligibility as a Responsible Person in Switzerland
• Pharmaceutical degree, or other natural sciences degree
• A minimum of 2 years pharmaceutical Quality experience, or other experience as recognized by Swissmedic
• Fluent in English and German
• Broad knowledge of Swiss and EU GxP requirements
• Solid understanding of Excel, Word, and quality management software (e.g., Trackwise)
• Excellent social skills: ability to build and maintain relationships with internal and external customers; highly Functioning team leader and team member in a dynamic business environment
• Leadership skills: Proven track record to empower and encourage others, drive meaningful change, and negotiate mutually beneficial outcomes.
• Strong social skills both written and verbal
• Problem solving ability.

You can expect a varied job in a dynamic and international environment. A workplace culture in which integrity, intensity, involvement and innovation are lived. A well-founded induction and task-specific training are a matter of course for us. You yourself settle your future in our company - make your contribution to our joint success!
As an equal opportunity employer, Thermo Fisher Scientific is committed to supporting underrepresented groups and does not discriminate on the basis of ethnicity, color, religion, gender, sexual orientation, gender identity, national origin, disability or legally protected status