QC Operations Scientist

2 weeks ago

Louth Co Louth, Ireland WuXi Biologics Ireland Limited Full time

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, US, EU, and Asia. The company currently employs over 10,000 employees worldwide, and are providingservices to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Job description: As QC Operations Scientist, you will be responsible for carrying out tasks and supporting projects relating to QC LIMS computer systems as LIMS administrator, sample management, and general QC-compliance functions while ensuring the highest standards of Good Laboratory Practices, regulatory requirements and quality within the business is adhered to. As part of the project the role will evolve based on project timelines. Organisation Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) 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 QC Operations Scientist, 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 QC Operations Senior Scientist. Essential Dutes and Responsibilities Ensure the tasks associated with the startup and routine operations of a QC Operations laboratory are carried out in a safe manner. Support QC Operations as Lab administrator for LIMS system i.e. complete LIMS configuration builds on storage locations, stability protocols, stock builds etc. Support QC Operations lab set-up, including laboratory design, equipment installation and qualification utilizing principles of Operational Excellence and Lean Labs. Support facility qualification, process validation, etc. Develop and maintain quality systems within the QC Operations Laboratory to ensure compliance to cGLP. Aiding in the identification and development of Contract Test laboratories and strategies. Development of training material for the QC Operations Laboratory personnel in particular training to LIM administrators and LIMS users. Perform additional duties at the request of the direct manager. Support QC Senior scientist in OOS, OOL, adverse trends, any excursion investigations, change controls, and CAPAs tasks. Author technical documents including methods protocols, qualification/ validation protocols and reports, SOPs, etc. Support Risk Assessments for projects and business innovation initiatives from a QC Operational perspective. Keep abreast of current corporate and regulatory trends and requirements pertaining to laboratory operations. Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings. Ability to handle regulatory inspections from FDA, EMA, etc. and cGMP audits from clients, as well as internal audits. Participate in relevant internal and external QC related audits. Ability to work in a team environment and independently as required. Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Biologics Policies and Standard Operating Procedures. Thorough understanding of current Good Manufacturing Practices Perform all duties in accordance with GMP requirements, SOPs and controlled documents Will be flexible to take on additional tasks and responsibilities at the discretion of the QC Operations Senior Scientist Will act as a role model for the QC function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Person Specification Technical Competencies Knowledge of LIMS System as administrator or completing LIMS configuration changes i.e. performing stock builds/stability build Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines desirable. Experience with regulatory/customer audits is desirable. Experience Experience in a large-scale Biopharmaceutical/pharmaceutical facility. Experience as a LIMS administrator. Experience with facility start-up projects (brown field or green field) is desirable. Experience in Training of personnel. Previous experience in a Quality Control/GMP environment is required. Knowledge Knowledge of the LIMS system is essential. Knowledge of analytical testing in support of biopharmaceutical manufacturing is preferred but not required. Knowledge of analytical testing in support of biopharmaceutical manufacturing is preferred but not required. Qualifications University degree in related science/quality discipline required. Behavioural Competencies Excellent communication, interpersonal and presentation skills Ability to think critically and demonstrate troubleshooting and problem-solving skills. Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities. Collaborative and inclusive approach to work and your colleagues. Flexible approach to work and a positive attitude will be a good fit within the team dynamic. Engage cross functionally in conjunction with a site-based team. 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 ator contact us via WuXi Biologics is an equal opportunities employer. Skills: LIMS QC Stability Protocols Stock Builds GMP Benefits: Bonus Canteen Life Assurance Paid Holidays Parking Pension VHI

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