QA Drug Substance Operations Specialist

As QA Drug Substance Operations Specialist you will be responsible for providing online QA oversight to Drug Substance manufacturing operations in WuXi Biologics in Dundalk Ireland. This is a crucial role within the Quality organisation with responsibility for directly supporting the manufacturing operations team daily ensuring compliance with cGMP and corporate and local SOPs.

Organization Description

WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. Were one of the worlds top three contract development and manufacturing companies for biopharmaceuticals we provide our clients with a world-leading open access technology platform. We enable our clients to research develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery development and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China the US the EU and Asia. We currently employ over 10000 people and provide services to more than 600 customers worldwide including the top 20 biopharmaceutical companies.

Department Description

As QA Drug Substance Operations Specialist you will be joining an organization where people of all backgrounds and experiences are respected and where we work together focused on changing this role you will be reporting to the QA Drug Substance Operations Group Leader.

Your Responsibilities

• In this role you will provide QA support to technology transfer and commercial manufacturing operations.
• Perform QA review of SOPs risk assessments change controls and other documentation as applicable associated with Drug Substance manufacturing operations
• Ensure that 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 that 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 that 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 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.
• Will act as a role model for the QA function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

Your Profile

The ideal candidate for this position will have the following:

Education

• A Bachelors degree in a technical discipline (e.g. biochemistry chemistry engineering) would be an advantage.

Knowledge/Experience

• Candidates from Manufacturing Operations Validation Engineering and other technical disciplines within the biotechnology and/or pharmaceutical industry will be considered butdemonstrated experience in Quality Management System pharmaceutical regulations and continuous/process improvement tools will be required.
• Experience in the biotechnology and/or pharmaceutical industry within a Quality operations role preferred.
• Experience in performing internal audits is ideal.
• Experience in supporting Technology Transfer projects would be an advantage.
• Demonstrated knowledge of Quality Management System and continuous/process improvement tools.

Personal skills

Required:

• Adaptable able to multi-task and handle tasks with competing priorities effectively to deliver site priorities.
• Demonstrated organisation and collaboration skills with a teamwork mind-set.
• Excellent communication skills (written and oral).
• Proactive attitude with good attention to detail.
• Analytical with demonstrated problem solving & root-cause analysis skills.
• Strong aptitude withability tointerprettechnical documentation.
• Strong knowledge of cGxP requirements and regulations.
• Knowledge of trouble shooting and problem-solving skills e.g. formal root cause analysis such as Ishikawa diagrams FMEA etc.
• Demonstrated knowledge of Quality Management System and continuous/process improvement tools.

As we extend our global reach we need colleagues interested in change in challenge and in building a new future together. Reach beyond yourself and discover your true potential!

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 - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential.

Apply now!

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