QA Technical Specialist

WuXi Biologics; Leinster; On-site; EUR 65,000 - 90,000; Full time

Job summary

WuXi Biologics Ireland is seeking a QA Technical Specialist to deliver technical QA support for NMI, NPI, TT and CI projects, collaborating with QA Lead DS Manufacture/QP, QA for Warehouse, DS QA, and QA Client Manager.

The ideal candidate will have a technical degree and strong cGxP knowledge, with experience in QA review of MT/CMC docs and Master Batch Records, plus familiarity with SAP/SUS processes. This role emphasizes cross-functional teamwork and adherence to SOPs and PROUD culture.

Qualifications

• Bachelor’s degree in a technical discipline is advantageous.
• Strong knowledge of cGxP requirements and regulations.
• Proficient in root cause analysis (e.g., Ishikawa, FMEA).
• Experience with Quality Management System and continuous improvement tools.

Responsibilities

• Ensure NMI, NPI, TT and Continual Improvement projects are executed by cross-functional teams in compliance with SOPs and cGMP.
• Monitor progress and escalate overdue actions to NPI/TT team.
• Perform QA review/approval of Technology Transfer and CMC documentation.
• Review and approval of Master Batch Records (MBRs).
• Perform cell bank qualification, receipt and release.
• Support item code and master data requests for SAP operations (SUS).
• Perform QA review of BOMs for SAP operations.
• QA main point of contact for Single Use System(s) and related reviews.
• Provide QA support for resolution of batch record observations, deviations, and handling tasks.
• Author and review SOPs applicable to the job description.
• May participate in the site internal audit program.
• Participate in cross-functional teams and projects.
• Perform additional duties as directed by supervisor.
• Act as a role model for QA and PROUD culture.

Skills

Technical documentation

cGxP knowledge

Root cause analysis

Quality management

Project management

Education

Bachelor’s degree in a technical discipline

Job description

As QA Technical Specialist, you will have responsibility to deliver technical QA support to New Material Introduction (NMI), New Product Introduction (NPI), Technology Transfer (TT) and Continual Improvement projects in WuXi Biologics Ireland. This is a crucial role within the QA organisation and will involve the provision of technical QA support to the Supply Chain, Manufacturing and Technology Transfer teams by working closely with the QA Lead DS Manufacture/QP, the QA for Warehouse team, the DS QA team, and the QA Client Manager to support NMI, NPI, TT and Continual Improvement projects. This role will liaise with clients in TT and CMC meetings and as part of QA documentation review.

Organization Description

WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's 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.

Department Description

As QA Technical Specialist, you will join 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 Quality Technical Lead.

Your Responsibilities

In this role, you will carry out essential duties.

• Ensure that New Material Introduction (NMI), New Product Introduction (NPI), Technology Transfer (TT) and Continual Improvement projects are executed by the cross-functional teams in compliance with SOPs and cGMP requirements.
• Monitor progress of NPI and Technology Transfer actions as detailed in the project plan/change control action list. Ensure that actions are performed by the assignee on time and in full. Escalate lack of progression of tasks and/or potential overdue tasks to NPI/TT team.
• Perform QA review and approval of Technology Transfer and CMC documentation.
• Review and approval of Master Batch Records (MBRs).
• Perform cell bank qualification, receipt and release.
• Support item code and master data request and revision process for SAP operations, specifically for Single Use Systems (SUS).
• Perform QA review of BOMs for SAP operations.
• QA main point of contact for Single Use System(s); including drawing, SUFD and quality documentation review, support NMI requirements for material and supplier qualification for SUSs, review and approve SUS specifications, ensure that polymeric compatibility assessments are being conducted by MSAT/MT teams, as required, and ensure that SUSs are managed in accordance with applicable site SOPs.
• Provide technical support to DS QA and WH QA teams for resolution of executed batch record observations, deviations, and abnormal material handling tasks (including supplier and service provider complaints) relating to NMI, NPI and/ or TT projects.
• Author and review SOPs applicable to the job description.
• May participate in the site internal audit program, as required.
• Participate in cross-functional teams and projects, as required.
• Perform additional duties at the request of direct supervisor.
• Will act as a role model for the QA function and also 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:

Qualifications

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

Technical Knowledge/Experience Required

• 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.
• A project management qualification would be an advantage.

Experience Preferred

• 3-5 years’ experience in the biotechnology and/or pharmaceutical industry is preferred.
• The preferences are 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 butdemonstrated experience in Quality Management System, pharmaceutical regulations and continuous/process improvement tools will be required.
• Experience in supporting Technology Transfer projects would be an advantage.

Personal skills

• Adaptable, able to multi-task and handle tasks with competing priorities effectively to deliver site priorities.
• Demonstrated organisation and collaboration skills with a teamwork mindset.
• Excellent communication skills (written and oral).
• Proactive attitude with good attention to detail.
• Analytical with demonstrated problem solving & root-cause analysis skills.

Other Requirements

• This position will not work a shift pattern, but the role may require occasional attendance at site out of normal working hours to support NPI/TT activities.
• Routine travel is not expected of this role, but occasional travel may be required to support NPI/TT activities, training, and auditing.

WuXi Biologics is an equal opportunities employer.