QA Client Specialist

WuXi Biologics; Leinster; On-site; EUR 45,000 - 65,000; Full time

Job summary

WuXi Biologics is seeking a QA Client Specialist in Ireland to manage client quality events and follow-ups under QAA terms. You will support preparation of QAAs, client calls, and KPI reporting, working with QA, QC, and PM teams to ensure timely closure of actions while adhering to cGMP and SOPs.

The role emphasizes collaboration with clients and internal groups, multi-tasking across audits, CAPAs, and document reviews, and maintaining alignment with PROUD values.

Qualifications

• Bachelor's degree in a technical discipline would be an advantage.

Responsibilities

• Ensure that Client quality event notifications and follow-ups are managed per the terms of the applicable Quality Assurance Agreement(s) (QAA(s)).
• Follow up on progress of Client Complaints, Audit CAPAs, APQRs, COAs, Change Controls, Document Review and Document Approvals.
• Support preparation and implementation of Quality Assurance Agreements (QAAs) with the Client, MAH, QP etc., as per the requirements of the project.
• Support the preparation and delivery of client calls and meetings to ensure that the requirements of Quality Assurance Agreements are being met, as required and as per agreed communication plans.
• Monitor and publish (as necessary) Quality and Delivery KPIs agreed with Client and provide regular updates on success of delivery to both internal and external stakeholders.
• Support the development and implementation of clear communication plans with project teams and Clients with respect to QA and compliance activities.
• Support audits and QA/QP visits, prepare responses to audit reports and track progress of audit CAPAs.
• Work collaboratively with Client, QA Batch Release, QP, PM group, and other internal and external groups, as necessary, to ensure timely closure of Client batch record reviews, including closure of Client comments.
• Perform all duties in accordance with cGMP and SOPs.
• Adhere to the WuXi Biologics corporate core values and PROUD culture.
• Perform additional duties at the request of direct supervisor.

Skills

Interpersonal skills

Communication skills

Multitasking

Urgency/Action orientation

Education

Bachelor's degree in a technical discipline

Job description

Department Description

As QA Client Specialist, you’ll 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 report to the QA Client Lead.

Your Responsibilities:

• Ensure that Client quality event notifications and follow-ups are managed per the terms of the applicable Quality Assurance Agreement(s) (QAA(s)).
• Follow up on progress of Client Complaints, Audit CAPAs, APQRs, COAs, Change Controls, Document Review and Document Approvals.
• Support preparation and implementation of Quality Assurance Agreements (QAAs) with the Client, MAH, QP etc., as per the requirements of the project.
• Support the preparation and delivery of client calls and meetings to ensure that the requirements of Quality Assurance Agreements are being met, as required and as per agreed communication plans.
• Monitor and publish (as necessary) Quality and Delivery KPIs agreed with Client and provide regular updates on success of delivery to both internal and external stakeholders.
• Support the development and implementation of clear communication plans with project teams and Clients with respect to QA and compliance activities.
• Support audits and QA/QP visits, prepare responses to audit reports and track progress of audit CAPAs.
• Work collaboratively with Client, QA Batch Release, QP, PM group, and other internal and external groups, as necessary, to ensure timely closure of Client batch record reviews, including closure of Client comments.
• Perform all duties in accordance with cGMP and SOPs.
• Adhere to the WuXi Biologics corporate core values and PROUD culture.
• Perform additional duties at the request of direct supervisor.

Requirements

Qualifications:

A Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering) would be an advantage.

Experience/Knowledge

• Minimum of 1-3 years’ experience in the biotechnology and/or pharmaceutical industry is preferred.
• The preference is for candidates from QA roles but candidates from QC, Manufacturing Operations, Validation, Engineering and other technical disciplines within the biotechnology and/or pharmaceutical industry will be considered.
• Experience assisting in audits or regulatory inspections would be an advantage.
• Knowledge of Quality Management System and continuous/process improvement tools would be an advantage.
• Basic working knowledge of cGxP requirements and regulations is required.
• Adaptable, able to multi-task and handle tasks with competing priorities effectively
• Strong sense of urgency with a drive to close actions to closure on time and in full
• Good interpersonal and communication skills