BioMarin International Limited | QA Associate

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. QA Associate - Fill Finish - Shanbally, Ringaskiddy, Cork Closing Date - 17th January 2025 Shift Role SUMMARY DESCRIPTION BioMarin is a high-performing, team based organisation, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills. As part of establishing sterile filling operations at the Shanbally facility, this role (which reports to the QA Operations Manager) will provide QA support for the start-up of the facility, before moving into routine QA support of same. The successful candidate will also have proven capability in promoting Quality across cross-functional teams, to deliver on-time high quality processes and products, whilst ensuring continuous process improvement. Key Responsibilities: Provide Quality direction and oversight of the start-up, technical transfer, operation, and continuous improvement of Sterile Drug Product Filling operations. Provide Quality input to Change Controls, Protocols and Reports ensuring scope of records are clear and implementation activities are robust and timely. Write, review and approve Standard Operating Procedures, Work Instructions, Quality Technical Agreements, Master Batch Records, Specifications and other GMP documentation in accordance with BioMarin Policies. Participates within inter-departmental and cross-functional project teams to immediately address issues and questions in real time to help ensure project timelines are achieved. Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements. Provide Quality input and guidance to ensure Lot Release (Components/Raw Materials/Drug Product) of high quality products in compliance with current Good Manufacturing Practices (GMPs). Compilation of Lot Release Packs as per requirements of SOPs, WIs and related FRMs. Provide Quality input to Deviations ensuring scope of record is clear and implementation activities are robust and timely. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable. Exercise judgment to determine appropriate action, ensuring proper escalation when issues are identified as per applicable procedures for compliance, escalation and corrections. Pro-actively identifies compliance risks and takes appropriate preventative actions. Proactively identify potential issues, lead root cause analysis, make recommendations and aid in implementation for more complex and non-reoccurring issues. Ensure high level of Quality / cGMP Awareness in the Project Team and Sterile Filling Team. Lead Area GMP Certification Activities. Support pre-approval Regulatory Inspection readiness to ensure regulatory approvals are obtained. Support all Quality Assurance elements needed to facilitate new product launches. QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS REQUIRED: Degree or 3rd level qualification (Science, Quality). QP Qualification would be an advantage. Demonstrated experience in Sterile Drug Product Filling and start-up of same. Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role. Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems. Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance. Demonstrated ability to work and succeed within teams as well as leading small project teams while maintaining and strengthening trust relationships with people on all levels. Strong organizational skills, including ability to follow assignments through to completion. Proficiency in PC skills such as Excel, Word, PowerPoint. Proven decision making capability with full accountability and responsibility. Demonstrated coaching skills. Excellent written and verbal communication skills. Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations. DESIRED: Experience in Sterile Drug Product Filling and start-up of same. Evidence of Continuous Professional Development. Evidence of Validation knowledge/experience. MES experience. Good knowledge of Lean / Continuous Improvement practices and root cause analysis. BEHAVIOURS: Always focused on the patient and customer needs. Resilient profile with the ability to deliver in a challenging environment. Ability to engage and manage multiple stakeholders to achieve the objective. Curious with learning agility. Operationally excellent, with attention to detail. Organised with systematic approach to prioritisation. Process orientated to achieve the business objective. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.