Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, the US, the EU, and Asia. The company currently employs over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Job description: As Senior QA for QC Specialist, you will play a key role in supporting the QC function to ensure the highest standards of professional excellence and quality assurance in the business, with responsibility for supporting the Pharmaceutical Quality System (PQS) in place, adhering to all regulatory, cGMP and company requirements and ensuring all necessary plans and standards are achieved by consistently maintaining a high level of quality. Organisation Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialisation) with global customers in the biopharmaceutical and healthcare industries. Were 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 Senior QA for QC Specialist, youll be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role youll be reporting to the QA for QC Senior Manager. Essential Duties and Responsibilities Ensure that QC functions, as applicable, are conducted according to appropriate cGMP behaviours and compliance to SOPs and other cGMP documentation, as applicable. Ensure that EudraLex GMP guidelines and all applicable cGMP guidelines are followed. Provide QA review and approval of SOPs, quality risk assessments, change controls and otherdocumentation, as applicable, associated with QC functions. Review and approval of QC and analytical data sections within the different documents e.g. Annual Product Quality Review, Quality Agreements, Service Level Agreements, etc. Act as SAP Key User for QM functions. Liaise with QC teams, as appropriate, to ensure that all deviations, investigations and dispensing review comments are adequately addressed and closed out in a timely manner as defined in SOPs. Work with Warehouse, SCM and QC teams, as appropriate, to ensure that all CAPAs, change controls, self-inspection observations, etc. relating to QC and sampling operations are addressed and closed out in the required time frame. Liaise with key stakeholders in supporting daily operations. Ensure clear communication on issues and timely escalation as applicable. Identify and drive opportunities for continuous improvement. Coordinate with internal Quality peers to ensure on-time disposition of drug substance material. Provide support for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions. Perform all duties in accordance with cGMP requirements, SOPs and controlled documents. Deputize the QA for QC Senior Manager whenever delegated. Will be flexible to take on additional tasks and responsibilities at the discretion of the QA for QC Senior Manager. Will act as a role model for the Quality Assurance function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Requirements Technical Competencies Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures). Demonstrated knowledge of cGMP and GLP 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 handling of Deviations and different laboratory investigations. Experience 3+ years experience in the biotechnology and/or pharmaceutical industries within a Quality role, preferably in QA or QC or Microbiology or Manufacturing Operations within the biopharmaceutical/ pharmaceutical industry. Experience working on QA/QC incoming material inspection or warehouse operations would be advantage. Experience working with SAP would be an advantage. Knowledge Demonstrated knowledge of Quality Management System and continuous/process improvement tools. Demonstrated knowledge of ICH, EU and FDA GMP regulation. Demonstrated knowledge of Good Laboratory Practices (GLP). Qualifications Preferable that the individual has qualification Degree in Biopharmaceutical/ Pharmaceutical Science or other related science discipline. Behavioural Competencies Essential to have: Proven decision-making capabilities. Demonstrated collaboration, negotiation, conflict resolution skills and inclusive approach with a teamwork mindset. Analytical, problem solving & root-cause analysis skills Able to challenge the status quo with a continuous improvement mindset. Excellent interpersonal, verbal, and written communication skills Self-starter and self-motivated; organized with good attention to details. 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. Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers expectations. Desirable: Business acumen/commercial awareness. Other Requirements There may be a requirement for occasional travel to locations within Ireland and overseas to support business needs. Must be willing to travel when required. There will be a requirement for direct reports to work shift pattern once the project phase is complete 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 vision - Any drug can be made, and any disease can be treated - dont 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 or contact us via WuXi Biologics is an equal opportunities employer. Skills: QC lab investigations deviations CAPAs Empower HPLC Trackwise Benefits: Bonus Laptop Life Assurance Paid Holidays Parking Pension VHI