Quality Specialist

Quality Specialist (QA for QC) – WuXi Biologics

As a Quality Specialist (QA for QC) you will be responsible for supporting the Pharmaceutical Quality System (PQS) in place, adhering to all regulatory, cGMP and company requirements.

Organisation Description
WuXi Biologics is a premier provider of biologics services (from discovery to commercialisation) 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.

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 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.

Department Description
As a Quality Specialist (QA for QC) 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 for QC Senior Manager.

Your Responsibilities

Provide QA support for site start‑up, technical transfer and routine operations within QC department.

Participate in the development, implementation and maintenance of the local Pharmaceutical Quality System (PQS).

QA support for routine operations within QC department.

Participate and lead as necessary, deviations, CAPA’s, change controls, suspect analytical result investigations, laboratory and site investigations.

Work with relevant departments to ensure timely closure of quality actions.

Experience in generation, review and approval of quality documentation as required i.e. SOPs, CoA’s, specification documents, protocols, reports etc.

Assist in/Co‑ordinate the preparation of reports such as the Annual Product Quality report.

Play an active part in the continued development of the Pharmaceutical Quality System (PQS) by constructively challenging deficiencies and inefficiencies.

Collaborating internally and also across the WuXi network to achieve quality goals.

To actively support the development/implementation of continuous improvement activities and other quality activities may be assigned as required.

Collate and review data to be used in reports, investigations, key performance indicators (KPIs) and other quality metrics.

Assist and participate in audits as required, including site regulatory audits and customer audits.

Perform all duties in accordance with GMP requirements, SOPs and controlled documents.

Flexibility to take on additional tasks and responsibilities at the discretion of the Senior Manager (QA for QC).

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:

Education

Degree qualification in biopharmaceutical science or related discipline.

Knowledge/Experience

5+ years’ experience in QA or QC.

Experience in a GMP facility, preferably in the biopharma/pharmaceutical industry.

Familiarity with ICH, EU, and FDA GMP regulation.

Knowledge and proven experience in implementing investigational tools, root cause analysis and driving closure of investigations.

Ability to conduct audits for QC area, to support our culture of compliance and to meet regulatory, market, EU, FDA, and Company standard.

Strong leadership competencies with demonstrated management skills.

Excellent interpersonal, verbal, and written communication skills.

Ability to think critically and demonstrate troubleshooting and problem‑solving skills.

Self‑starter and self‑motivated; organized with good attention to detail.

Comfortable working in a fast‑paced environment and able to adjust workloads based on changing priorities.

Results oriented, with the ability to manage multiple priorities in a short period of time.

Collaborative and inclusive approach to work and your colleagues.

Excellent problem solving and troubleshooting skills.

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 – don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential.

Apply now

Would you like to know more before you apply? Please visit us at https://www.wuxibiologicscareers.ie or contact us via talentacquisition@wuxibiologics.com

WuXi Biologics is an equal opportunities employer.

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