GMP/GDP QA Auditor

CK Group; Allschwil; Vor Ort; CHF 80’000 - 100’000; Vollzeit

Zusammenfassung

CK Group is seeking a (Senior) GMP / GDP QA Auditor in Allschwil, Switzerland. The role involves leading audits, ensuring compliance with GMP/GDP regulations, and promoting quality standards across the organization. Ideal candidates will have a strong background in pharmaceutical quality assurance with a focus on regulatory compliance, and possess excellent communication and organizational skills.

Leistungen

Competitive contractor rate

Professional development opportunities

Mission-driven organization culture

Qualifikationen

• Minimum 3 years’ experience in Auditing, 1 as Lead Auditor.
• Excellent knowledge of relevant GMP/GDP and international quality regulations.
• Fluent in English and knowledge of another European language is beneficial.

Aufgaben

• Lead external QA audits and conduct GMP/GDP audits.
• Create and maintain Quality Agreements with vendors.
• Report self-inspection findings to management.

Kenntnisse

Attention to detail

Organizational skills

Multitasking

Communication skills

Ausbildung

University degree in Pharmacy, Chemistry or relevant technical/science degree

Jobbeschreibung

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.
• Opportunity to work in a mission-driven organization dedicated to maintaining the highest quality standards in pharmaceutical operations.
• Professional development and growth opportunities.