Senior Quality Assurance Engineer Life Sciences

We are SIMABS

SIMABS is a forward-thinking biotechnology venture dedicated to delivering cost-effective therapeutic monoclonal antibodies to the biopharmaceutical industry. With a focus on simplicity, innovation, and a vibrant start-up culture, we are setting new standards in biopharmaceutical manufacturing. If you’re ready to join a dynamic team and help shape the future of our industry, SIMABS could be your perfect match!

Job content

As our Senior Quality Assurance Engineer, you will be a critical part of our quality team. You will ensure the highest quality standards in our processes by combining project-specific QA tasks with day-to-day quality management activities. Your expertise will help maintain and continuously improve our Quality Management System (QMS) while working closely with the Head of Quality.

Responsibilities:

Project Quality Assurance

• Product Implementation: Support the implementation of new products at our GMP site.


• Technical Reviews: Review and discuss tech transfer data packages and implementation documents.


• Validation: Prepare and review project-specific validation protocols and reports.

Routine Quality Assurance

• Documentation: Draft master batch records and conduct comprehensive batch record reviews.


• Environmental Monitoring: Support and review environmental monitoring activities.


• Material Management: Release incoming materials and develop detailed material specifications.


• Supplier Oversight: Assist in the qualification and requalification of suppliers.


• Compliance: Ensure strict adherence to Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

Quality Management System (QMS) Maintenance

• Monitoring: Track and follow up on events, planned deviations, supplier complaints, OOS, CAPA, and change requests.


• Documentation Management: Write and review SOPs, work instructions, and forms; archive records and files.


• Collaboration: Prepare documentation for management reviews and collaborate closely with the Head of Quality to enhance our quality processes.