QA Client Specialist

QA Client Specialist

The QA Client Specialist will work to ensure that operational deliverables for specific product project(s) are delivered in compliance with cGMP applicable Quality Assurance Agreements (QAAs) and contracts. This role supports all aspects of Client interactions including but not limited to; management of QAA deliverables (e.g. quality event notification and resolution) management of Client batch record review Client batch disposition QP/QA Batch release liaison to facilitate on-time shipment QAA implementation and revision Client Audits and Client QA metrics compilation and publishing.

Department Description

As QA Client Specialist youll 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 Bachelors degree in a technical discipline (e.g. biochemistry chemistry engineering) would be an advantage.

Technical Competencies

• Good technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures).

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.

Behavioural Competencies

• 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
• Good organisational skills
• Proactive attitude
• Excellent attention to detail.