We are seeking a highly motivated QA for QC Expert to join our team. In this role, you will play a pivotal part in ensuring the highest quality standards for our drug products by providing dedicated quality oversight of our QC operations. This position offers a unique opportunity to contribute to the successful operation and compliance of our analytical laboratories.
 
Purpose
Your primary mission is to ensure that all laboratory testing, analytical methods, and data management activities are performed in strict compliance with GMP, data integrity principles, and approved procedures. By providing quality oversight of QC operations—including method validation, instrument qualification, and sample management—you will ensure the reliability of test results through independent verification and risk-based controls, ultimately protecting the integrity of product release decisions.
 
Key Responsibilities & Accountabilities

• Method & Equipment Oversight: Lead the quality oversight for analytical method validation and equipment CQV (Commissioning, Qualification, and Verification) and lifecycle management.
• GMP Documentation & Review: Review and approve GMP documentation, including material specifications, analytical records, QC results, and CoA/TSE/BSE statements.
• Operational Quality Support: Perform regular GMP walks and provide on-floor oversight for sampling, transport, and general QC operations.
• Material Management: Manage material labels and ERP material status (excluding Drug Product), and handle the release of materials.
• Systems & Administration: Act as the MODA administrator and oversee sampling plans and APS (Aseptic Process Simulation) quality requirements.
• Quality Systems Management: Drive the management of Deviations, CAPAs, and Change Controls within the QC environment and support laboratory investigations.

We are looking for someone with:

• Education: A Master’s degree in science (Biology, Microbiology, Pharmacy, or similar).
• Technical Experience: Proven experience in a QA role within a GMP-regulated environment for drug product manufacturing or testing.
• Specialized Knowledge: Strong understanding of QC operations, analytical methods, and data integrity principles. Experience in microbiology is a plus.
• Language Skills: Fluency in both spoken and written English is required.
• Professional Attributes: An independent and efficient team player who thrives in interdisciplinary collaboration and demonstrates a high degree of flexibility in problem-solving.
• Mindset: A proactive approach to contributing ideas and a strong willingness to take on responsibilities.

We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.
 
Here's what sets ten23 apart:

• A valuable and impactful career development opportunity in an inspiring environment  
• Flexible working arrangements and environment with an open culture and diverse workforce  
• The opportunity to work with and learn from highly qualified and experienced employees  
• Our learning and self-developing culture offers a wide range of training options  
• Competitive pension fund plan, annual bonus, and other financial and non-financial benefit 

At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws.

For more information and clarification, please connect with Amrith (amrith.kiran@ten23.health) from our Talent team!