Job Description:
QA Drug Substance Operations Specialist
This role is responsible for providing online QA oversight to Drug Substance manufacturing operations in Wu Xi Biologics, Ireland.
As a QA Drug Substance Operations Specialist, you will directly support the manufacturing operations team daily, ensuring compliance with cGMP and corporate/local SOPs.
Responsibilities:
* Provide QA support to technology transfer and commercial manufacturing operations
* Perform QA review of SOPs, risk assessments, change controls, and other documentation associated with Drug Substance manufacturing operations
* Ensure Drug Substance manufacturing operations are conducted according to appropriate cGMP behaviors and in compliance with SOPs, batch manufacturing records, and other cGMP documentation as applicable
* Liaise with Manufacturing Operations to ensure all deviations, investigations, and batch manufacturing record reviews are performed, addressed, and closed out in a timely manner as defined in SOPs
* Work with Manufacturing Operations to ensure all CAPAs, change controls, self-inspection observations, etc., relating to manufacturing operations are addressed and closed out in the required time frame
* Liaise with manufacturing operations, QA, QC, Engineering, MSAT, etc., in supporting daily operations
* 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 drug substance material
* Provide support for the preparation of regulatory submissions and inspection readiness activities
* Perform onsite quality monitoring of GMP areas
* Provide support for health authority inspections, including responses to inspection observations, monitoring of follow-up actions
* Perform additional duties at the request of direct supervisor
* Flexibility to take on additional tasks and responsibilities at the discretion of the QA Drug Substance Operations Group Leader
Requirements:
* Bachelor's degree in a technical discipline (e.g., biochemistry, chemistry, engineering)
* Candidates from Manufacturing Operations, Validation, Engineering, and other technical disciplines within the biotechnology and/or pharmaceutical industry will be considered
* Demonstrated experience in Quality Management System, pharmaceutical regulations, and continuous/process improvement tools required
* Experience in the biotechnology and/or pharmaceutical industry within a Quality operations role preferred
* Experience in performing internal audits ideal
* Experience in supporting Technology Transfer projects advantageous
* Demonstrated knowledge of Quality Management System and continuous/process improvement tools
Wu Xi Biologics is a world-class biologics services provider, working with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development, and manufacturing in the fast-growing field of biologics to benefit patients worldwide.
As a QA Drug Substance Operations Specialist, you will join an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.
We have sites/offices in China, US, EU, Asia, and Israel. We currently employ over 10,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies.
Apply now if you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission - Any drug can be made, and any disease can be treated - don't miss out on this opportunity to join us and reach beyond yourself and discover your true potential.