The company seeks a QA Associate for a 1-year on-site contract in Bern to support GMP-compliant processing of quality issues within a specialist biotherapeutics manufacturing team.
This position supports a dedicated team at the client's Bern headquarters, focusing on the GMP-compliant handling of deviations, complaints, and complex quality matters. The role contributes to a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide.
Responsibilities
- Provide consulting and support for aseptic manufacturing and microbiological laboratory operations.
- Ensure production activities adhere to GMP standards through review and compliance checks.
- Control, review, and document work steps, including the evaluation of processes in aseptic production.
- Assist in training and requalifying staff involved in aseptic production.
- Conduct initial assessments for deviations in aseptic filling and help define investigation strategies.
- Support the operations group in investigating deviations and defining corrective and preventive actions (CAPAs).
- Review investigation reports in German and English to assess compliance and risk.
- Participate in preparing for internal and external inspections by handling deviations.
- Support the review of specification documents.
Requirements
- Hold a relevant working/residency permit or possess Swiss/EU citizenship.
- Possess a degree in a scientific field, preferably Pharmacy, Chemistry, or Biology.
- Have 1-2 years of experience in Quality Assurance or Quality Control.
- Have 1-2 years of experience with Quality Management Systems (QMS).
- Demonstrate fluency in both English and German.
Nice to have
- Experience working within a pharmaceutical company and a GMP environment.
About the company
The client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. The company is committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases, and other rare diseases.
- The company is committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases, and other rare diseases.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.