We are seeking a Quality Assurance Manager to oversee compliance and customer Quality Agreement (QAA) activities for Drug Product manufacturing in Visp. This role involves collaboration with Drug Product Services and Drug Substance teams, acting as the primary QA contact for customer-related quality topics and managing deviations, complaints, changes, and technical issues.
Key Responsibilities:
- Supervise QAA and compliance activities.
- Establish and negotiate Quality Agreements in close collaboration with other departments.
- Act as the primary QA contact for quality-related customer inquiries.
- Represent QA in cross-functional teams and customer meetings during technical transfer.
- Support and approve project / product specific risk assessments or regulatory specific risk or gap assessments.
- Review and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc.
- Assess, review and approve quality records e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions in line with current local SOPs.
- Author, review and approve GMP-relevant documents and SOPs.
- Support continuous improvement programs and risk assessments.
Your Profile:
- 5-10 years of experience in Quality Assurance within the pharma/biotech industry.
- Expertise in GMP compliance, deviation management, and quality agreements.
- Strong communication skills, ability to collaborate with cross-functional teams.
- Fluent English, German a plus.
Contract Duration: 8 Months
How to Apply:
For more information, please apply with your CV.
Please note, only those with the right to work in Switzerland can apply!
