Senior QA Drug Substance Operations Specialist

WuXi Biologics; Dundalk; Vor Ort; EUR 90.000 - 110.000; Vollzeit

Zusammenfassung

WuXi Biologics in Dundalk, Ireland seeks a Senior QA Drug Substance Operations Specialist to provide online QA oversight of Drug Substance manufacturing operations. You will ensure compliance with cGMP and internal SOPs while supporting technology transfer, change controls, deviations, investigations and batch reviews to maintain high-quality drug substance production.

The role involves collaboration with Manufacturing Operations, QA, QC, Engineering and MSAT, and includes preparation for

Qualifikationen

• Strong knowledge of cGxP requirements and regulations.
• Experience in biotechnology/pharmaceutical quality operations.
• Ability to interpret and review technical documentation.
• Demonstrated communication and collaboration skills.

Aufgaben

• Provide online QA oversight to Drug Substance manufacturing operations.
• Perform QA review of SOPs, risk assessments, change controls and other documentation.
• Ensure operations comply with cGMP and SOPs.
• Liaise with Manufacturing Operations to address deviations, investigations, and batch reviews.
• Support CAPAs, change controls, and internal/external inspections.
• Support regulatory submissions and inspection readiness activities.
• Act as substitute for QA DS Operations group lead as required.
• Support recruitment activities and cross-functional projects.

Kenntnisse

Analytical thinking

Communication

Problem solving

Technical interpretation

Adaptable

Ausbildung

Bachelor's degree in a technical discipline

Tools

Quality Management System (QMS) tools

Jobbeschreibung

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

Department Description

As Senior 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 lives. In this role you will be reporting to the QA Drug Substance Operations Group Leader.

Your Responsibilities

• Providing 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 cGMPbehaviors and in compliance with SOPs, batch manufacturing records and other cGMP documentation asapplicable.
• Liaise with Manufacturing Operations to ensure that all deviations, investigations, and batch manufacturingrecord 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-inspectionobservations, etc. relating to manufacturing operations are addressed and closed out in the required timeframe.
• 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, andmonitoring of follow up actions.
• Act as substitute for QA DS Operations group lead as appropriate e.g. attend meetings as required
• Support client interactions in relation to batch documentation review activities
• Support timely and efficient release of biological drug substance batches
• Support recruitment activities
• Participate in cross-functional teams and projects, as required
• Flexibility to take on additional tasks and responsibilities at the discretion of the QA Drug Substance grouplead.
• Flexibility to take on additional tasks and responsibilities at the discretion of the QA Director/ QMS Lead/QP.
• Will act as a role model for the QA function and also the wider organisation in adherence to the WuXicorporate core values and PROUD culture.

Requirements

• Strong aptitude with ability to interpret technical documentation.
• Strong knowledge of cGxP requirements and regulations.
• Knowledge of trouble shooting and problem-solving skills e.g. formal root cause analysis such as Ishikawadiagrams, FMEA etc.
• Demonstrated knowledge of Quality Management System and continuous/process improvement tools.

Experience

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

Knowledge

• Demonstrated knowledge of Quality Management System and continuous/process improvement tools.

Qualifications

• A Bachelor's degree in a technical discipline (e.g. biochemistry, chemistry, engineering) would be anadvantage.
• Adaptable, able to multi-task and handle tasks with competing priorities effectively to deliver site priorities.
• Demonstrated organization 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.
• Able to challenge the status quo with a continuous improvement mindset.
• Act as role model / mentor/ coach for peers
• Drive identified QA DS team activities

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