Quality Assurance Manager
Panda International
- Suisse
- CDI
- Temps-plein
Business Sector Pharmaceutical
Contact email
Job ref 23188
Published about 4 hours agoJob Description:As a member of the Quality Assurance team specializing in Bioconjugates, you will play a pivotal role in ensuring the production of Active Pharmaceutical Ingredients (APIs) adheres to Good Manufacturing Practice (GMP) standards. Your responsibilities will encompass various aspects of quality assurance, including supporting contract manufacturing operations, advising development, production, and analytical departments on GMP compliance, and serving as the primary quality contact for our clients during GMP audits.Key Responsibilities:Ensure GMP Compliance: Monitor and ensure that all production processes related to Bioconjugates adhere to GMP standards.Support Contract Manufacturing: Provide guidance and support to contract manufacturing activities, ensuring alignment with GMP requirements.Documentation Review: Verify manufacturing documentation for compliance, process change controls, and review/approve deviations and Out of Specification (OOS) results.Client Interaction: Act as the primary quality interface for clients, representing the organization during their GMP audits and addressing any quality-related inquiries or concerns.Key Requirements:Education: Bachelor's degree in Life Science (microbiology, biotechnology, chemistry) or related field.Experience: 3-5 years of relevant experience in the biopharmaceutical industry, with a strong background in GMP compliance.Communication Skills: Excellent communication skills, with the ability to effectively collaborate with stakeholders across different departments.Technical Proficiency: Experience with quality management systems such as TrackWise, SAP, Laboratory Information Management Systems (LIMS), and Document Management Systems (DMS) is preferred.Language Skills: Fluency in English (both written and spoken) is essential for stakeholder communication. Proficiency in German (B1 level) is required for daily interaction with colleagues.