In this role, you will oversee compliance and customer quality agreement activities for drug product operations. You will collaborate closely with various teams to establish and negotiate quality agreements, serve as a point of contact for quality assurance inquiries, and manage interactions related to changes and complaints. This position requires a proactive approach to ensure effective execution of drug product processes while maintaining high-quality standards.
Place of Work: Visp
Project Duration: Approx. 8 Months
Starting Date: 01/05/2025
Key Responsibilities
1. Supervise compliance and customer quality agreement activities for drug product operations
2. Establish and negotiate quality agreements in collaboration with relevant teams
3. Serve as the primary point of contact for quality assurance-related inquiries and complaints from customers
4. Manage interactions regarding changes, deviations, technical complaints, and out-of-specification results
5. Represent quality assurance in cross-functional teams and maintain effective interfaces with manufacturing, quality control, and engineering teams
6. Act as the quality assurance representative in project teams and customer meetings during technical transfers
7. Support and facilitate project-specific risk assessments and regulatory gap assessments
8. Review and release product-specific documentation, including process descriptions, manufacturing protocols, and test plans
9. Collaborate closely with quality control project leaders and support new product introductions
10. Assess, review, and approve quality records such as deviations, change controls, and corrective actions
11. Author, review, and approve GMP-relevant documents and standard operating procedures
Candidate Profile
1. 5-10 years of relevant work experience in quality assurance (or related fields)
2. Strong understanding of quality management systems and regulatory requirements
3. Ability to manage multiple projects and priorities in a fast-paced environment
4. Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams
5. Languages: Proficiency in English is mandatory, German is a plus
Job ID 41180337
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