About Us
ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.
Your mission
We are looking for a dedicated QA Manufacturing Lead 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.
Your profile
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.
Why us?
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.
Contact
For more information and clarification, please connect with Amrith (amrith.kiran@ten23.health) from our Talent team!
