GMP/GDP QA Auditor

CK QLS are looking for a (Senior) GMP/GDP QA Auditor, to join our team in Allschwil, Switzerland. As a mission-driven organization, we are dedicated to ensuring GMP/GDP compliance at third party service providers and maintaining the highest quality standards in pharmaceutical operations.

Responsibilities:
Lead in establishing external QA Audit and internal self-inspection annual Plan.
Conduct GMP/GDP audit and self-inspections and coordinate with internal personnel and suppliers.
Promptly report critical self-inspection findings to the Responsible Person and Management.
Create, implement, maintain, and work with Vendors on establishing Quality Agreements.
Interface between quality/regulatory/compliance personnel and operations to identify applicable regulatory and compliance requirements.
Manage, review and approve change controls, deviations and CAPAs.
Support the preparation of Regulatory Authority Inspections.
Monitor changes in quality regulations and initiate required activities to maintain compliance.
Promote GxP and Quality mindset at all levels within the organization.
Qualifications:
University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum.
Minimum 3 years’ experience in Auditing, 1 as Lead Auditor.
Excellent knowledge of relevant GMP/GDP and international quality regulations.
Ability to work on multiple projects with various disciplines and to manage complex projects.
Strong attention to detail, excellent organizational skills, and ability to multitask effectively.
Fluent verbal and written communication skills in English and at least basic knowledge of an additional European language.
Day-to-day:

As a (Senior) GMP/GDP QA Auditor, you will be responsible for leading external QA audits, conducting GMP/GDP audits and self-inspections, and ensuring compliance with quality regulations. You will also collaborate with cross-functional teams to obtain key performance indicators for the site and support the organization of Quality Management Review meetings.

Benefits:
Competitive contractor rate.
Fulltime schedule.
Opportunity to work in a mission-driven organization dedicated to maintaining the highest quality standards in pharmaceutical operations.
Professional development and growth opportunities.
Apply:

If you are looking for a new challenge and would like to know more them please apply and use (Apply online only) in all communications.  

All applicants must be an EU/EFTA Citizen or valid Swiss work Permit