Biologics Quality Assurance Lead
2 weeks ago
About WuXi Biologics Ireland Limited
">We are a world-class biologics services provider, offering a comprehensive range of services from discovery to commercialization. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide.
">With our global presence in China, the US, the EU, Asia, and Israel, we provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.
">About the Role
">We are seeking an experienced QC In Process Team Lead to join our team in Dundalk. As a key member of the QC Team, you will lead a range of technical projects and activities in the QC In Process group at WuXi Biologics.
">The site is focused on start-up activities involving commissioning and qualification aligned with project timelines. As part of the project, the role will evolve based on project timelines.
">Your Responsibilities
">- ">
- Support the execution of the strategy and business planning processes, ensuring cross-functional collaboration.">
- Develop and maintain high-level scientific achievements for the company.">
- Provide the highest quality analytical support for Biologics manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs, and safety regulations.">
- Serve as a technical expert supporting applicable non-conformances, atypical/OOS investigations, change controls, deviations, and CAPAs.">
- Manage In-process team shift rota and lead a team of QC In Process Scientists and Associate Scientists.">
- Collaborate with MFG and QC functional teams and other departments to support site operations.">
- Seek opportunities for continuous process improvements/improved operational excellence.">
- Ensure the tasks associated with the start-up and routine operations applicable to the role are carried out in a safe manner.">
Your Profile
">We are looking for an experienced professional with a strong background in QC and leadership skills. The ideal candidate will have:
">- ">
- 8+ years of experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field.">
- Experience working in the Biologics industry, with knowledge of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals.">
- University degree in related science/quality discipline required.">
- Strong leadership competencies with demonstrated management skills, excellent interpersonal, verbal, and written communication skills, and ability to think critically and demonstrate troubleshooting and problem-solving skills.">
About Us
">We are an equal opportunities employer and offer a competitive benefits package, including bonus, life assurance, paid holidays, parking, pension, and VHI.
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