Job Description
QA Operations Specialist role at Wu Xi Vaccines, a subsidiary of Wu Xi Biologics, involves ensuring quality and compliance in vaccine manufacturing operations.
Wu Xi Vaccines, a subsidiary of Wu Xi Biologics, focuses on human vaccine discovery, development and manufacture. An exciting new addition to the Wu Xi Biologics family, Wu Xi Vaccines will bring to the global vaccine industry the world-class integrated platforms and CDMO business model on which Wu Xi Biologics reputation is based.
In development is an integrated vaccine manufacturing facility with a 240 million US Dollar investment, including drug substance manufacturing (DS), drug product manufacturing (DP), Manufacture Science and Technology Labs (MS&T) as well as Quality Control labs (QC), dedicated to manufacturing our partner's vaccine products for the global market.
As QA Operations Specialist, you will be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.
Key Responsibilities:
- Provide QA oversight and support to technology transfer and commercial manufacturing operations including self-inspections
- Perform QA review of SOPs, risk assessments, protocols, change controls, deviations and other documentation, as applicable, associated with DS/DP manufacturing operations
- Perform executed batch reviews for technology transfer and commercial operations
- Ensure that DS/DP manufacturing operations are carried out aseptically and in line with c GMP regulations and in compliance with SOPs, batch manufacturing records and QMS
- Liaise with stakeholders to ensure all CAPAs, change controls, self-inspection observations, relating to manufacturing operations are addressed and closed out in the required time frame
- Perform deviations, investigations, and batch manufacturing record reviews and close them out in a timely manner as defined in SOPs
- Liaise with manufacturing operations, QA, QC, Engineering, MSAT, CQV, SCM etc. in supporting daily operations and deadlines
- Ensure clear communication on issues and timely escalation as applicable
- Identify opportunities for continuous improvement
- Support internal Quality peers to ensure on-time disposition of DS/DP material
- Provide support for the preparation of regulatory submissions and inspection readiness activities
- Perform onsite quality monitoring of GMP areas including oversight of aseptic and cleanroom behaviours, environmental monitoring and visual inspection
- Provide support during health authority inspections including responses to inspection observations, monitoring of follow up actions
- Perform additional duties at the request of direct supervisor
Education & Experience:
- Degree in Science preferably with a microbiology background or related discipline or equivalent qualification with experience
- Experience in the vaccines/ biotechnology and/or pharmaceutical industry within a Quality Operations role
- Candidates from Manufacturing Operations, Validation, Engineering, and other technical disciplines within the biotechnology, microbiology and/or pharmaceutical industry will be considered with demonstrated experience in Quality Management System, pharmaceutical regulations and continuous/process improvement tools
- Experience in performing internal audits
- Strong level of knowledge of EU, international and legislative requirements
- Demonstrated experience within highly regulated environment
- Strong aptitude with ability to interpret technical documentation
- Strong knowledge of c Gx P requirements and regulations
- Knowledge of trouble shooting and problem-solving skills, e.g., formal root cause analysis such as Ishikawa diagrams, FMEA etc.