Consultant Quality Assurance (QA/RA)
gempex GmbH
full-time
Posted on:
Location Type: Office
Location: Sisseln • 🇨🇭 Switzerland
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Independent management of client projects in the areas of QA/QM/RA
- Consultancy and operational support on GxP topics
- Establishment and optimization of GxP quality systems
- Support during inspections and conduct of audits
- Consulting on consumer health products
- Support with product classification and delineation questions
- Preparation and submission of regulatory/marketing authorization applications
- Life cycle management (variations, renewals)
- Assistance in expanding and further developing services
Requirements
- Degree in a natural science (Pharmacy, Chemistry, Biotechnology) or equivalent
- Ability to quickly familiarize yourself with different areas of responsibility
- Several years of experience in the life sciences industry within a GMP/GDP-regulated environment
- Several years of experience in QA and regulatory submissions
- Good knowledge of Swiss regulations
- Experience in the consumer health sector is desirable
- Independent, solution-oriented working style
- Confident appearance, team player with strong communication skills
- Very good German and English skills
Benefits
- Exciting and varied projects
- A collegial team and a supportive mentor
- Flexible location and working hours model
- Permanent employment contract(s)
- Internal and external training opportunities
- Open corporate culture with short decision-making processes
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GxPQAQMRAregulatory submissionslife cycle managementproduct classificationauditsconsultancyoperational support
Soft skills
solution-oriented working stylestrong communication skillsteam playerindependent managementability to familiarize quickly
Certifications
degree in natural sciencePharmacyChemistryBiotechnology