We are looking for a dedicated QA Manufacturing Specialist to be our quality champion on the manufacturing shop floor. In this role, you will play a critical part in maintaining Good Manufacturing Practices (GMPs), ensuring that every product meets our rigorous quality standards.

Your responsibilites will include, 

1. Real-Time Shop Floor Oversight

• Perform on-the-floor quality assurance support during manufacturing, cleaning, and environmental monitoring operations.
• Monitor adherence to GMP practices during critical manufacturing steps (e.g., line clearance, material dispensing, equipment setup).
• Witness and verify critical process steps, in-process controls (IPCs), and reconciliations.

2. Line Clearance and Batch Execution Monitoring

• Perform and document line clearances before manufacturing operations.
• Review manufacturing processes in real time for compliance with approved batch records and SOPs.
• Ensure proper material handling, labeling, and segregation during production.

3. Deviations and Issue Escalation

• Identify and report deviations or abnormal events on the shop floor.
• Support or lead immediate impact assessment and documentation of on-the-floor deviations.
• Ensure timely escalation and coordination with QA and production leadership for resolution.

4. Batch Record Review and GMP Documentation

• Review completed batch manufacturing records for accuracy, completeness, and compliance.
• Ensure timely corrections to documentation issues and assist operators in proper GMP documentation practices.
• Verify logbooks, equipment use records, and cleaning records on the shop floor.

5. Support for Interventions and Aseptic Practices (if applicable)

• Observe and assess interventions during aseptic operations for compliance with aseptic technique and contamination control.
• Support environmental monitoring activities, gowning practices, and cleanroom behavior compliance.

6. Participation in Routine Checks and Audits

• Conduct routine walkthroughs and spot checks to assess compliance with housekeeping, gowning, and other GMP standards.
• Participate in internal audits and regulatory inspections as needed, providing on-the-floor knowledge and documentation.

7. Shop Floor Training and Coaching

• Provide on-the-job coaching and GMP guidance to operators and technicians.
• Reinforce good documentation practices (GDP) and quality culture.

8. Support for Investigations and CAPAs

• Provide input into root cause analysis based on first-hand observations.
• Support implementation and follow-up of corrective and preventive actions directly related to shop floor findings.

We are looking for someone with, 

• A strong background in quality assurance within a pharmaceutical or regulated manufacturing environment, with a solid understanding of GMP (Good Manufacturing Practices).
• Good understanding of aseptic process and its core requirements
• Excellent communication and coaching skills to effectively guide production teams and reinforce a culture of quality.
• The ability to make sound decisions and manage deviations in a fast-paced setting.
• A collaborative spirit and a genuine passion for ensuring compliance and product integrity.

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!