GMPGDP QA Auditor
GMPGDP QA Auditor
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Salary Not Disclosed
1 Vacancy
Job Description
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 136 286 in all communications.
All applicants must be an EU/EFTA Citizen or valid Swiss work Permit.
Employment Type
4
