Direct message the job poster from CTC Resourcing Solutions AG
Our client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases, and other rare diseases.
We are seeking a highly skilled Quality Assurance Associate for a 12-month contract position at our client's headquarters in Bern. In this role, you will be part of a team responsible for ensuring GMP-compliant processing of deviations, complaints, and complex quality issues, supporting the high-quality standards of products for customers. Daily tasks include collaboration with both national and international health authorities. Fluency in both English & German is mandatory
Main Responsibilities:
1. Coordination and Investigation: Manage and investigate product complaints and adverse event reports.
2. CAPA Actions: Ensure timely and quality-compliant investigations (sometimes across multiple sites) and implement corrective and preventive actions (CAPA).
3. Communication with Authorities: Prepare communications for health authorities and ensure compliance.
4. Cross-Functional Collaboration: Work closely with production teams and other internal departments.
5. Audit Preparation and Support: Prepare for regulatory audits/inspections and assist in responding to inquiries from regulatory agencies.
Qualifications & Experience:
1. Educational Background: Degree in a scientific field (preferably Pharmacy, Chemistry, or Biology).
2. Experience: Ideally, experience within a pharmaceutical company and GMP environment.
3. Skills:
o High social competence and team-oriented mindset.
o Strong enthusiasm, analytical thinking, and effective communication skills.
o Precise and reliable work approach with the ability to prioritize effectively.
o Flexibility and ability to work independently as well as in a team, maintaining composure in fast-paced environments.
4. Languages: Proficiency in German and English, both spoken and written.
Would you like to learn more about CTC and the opportunity outlined? Please get in contact with us: you may either use the 'apply now' button or write an email to ashwini.shirvaikar@ctcresourcing.com
Seniority level
Associate
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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