We are seeking a QA Digital Manufacturing Lead to provide quality oversight and guidance for the implementation of digital solutions within a regulated pharmaceutical manufacturing environment.
This role is central to driving Review by Exception (RBE), electronic Batch Records (eBR), and paperless operations, ensuring robust compliance with GMP and data integrity standards while optimizing operational efficiency.
The Role:
- Provide QA guidance for the design, implementation, and optimization of eBR and paperless manufacturing workflows.
- Ensure all digital manufacturing solutions align with GMP regulations, data integrity principles (ALCOA+), and international regulatory body expectations.
- Define and approve RBE strategies, including deviation thresholds, critical exception handling, and streamlined QA review models.
- Partner closely with Manufacturing, Automation, IT, and Quality teams to embed Quality-by-Design (QbD) directly into digital systems.
- Review and approve quality requirements, risk assessments, and validation/Computer Software Assurance (CSA) deliverables for digital plant systems.
- Maintain inspection-ready digital processes, ensuring all automated workflows and systems are highly defensible and thoroughly documented
Requirements:
- Strong Quality Assurance background within a GMP-regulated pharmaceutical manufacturing environment.
- Associate's or Bachelor's Degree in Engineering, Automation, Manufacturing Engineering, Life Sciences or a related technical discipline.
- Hands-on experience implementing or managing eBR, Manufacturing Execution Systems (MES), or equivalent digital manufacturing platforms.
- Deep understanding of Review by Exception (RBE) concepts and paperless batch release methodologies.
