Senior Manager, Quality Operations Systems
في Viatris Inc.
في
Ireland
نُشرت يوم January 8, 2024
تفاصيل الوظيفة
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Senior Manager, Quality Operations Systems
Solicitar locations Little Island, Cork, Ireland time type Tiempo completo posted on Publicado ayer job requisition id R5641657 Upjohn Manufacturing Ireland Unlimited En VIATRIS, vemos la atención médica no como es, sino como debe ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en evolución. Viatris permite a las personas de todo el mundo vivir de manera más saludable en cada etapa de la vida. Lo hacemos a través de: Acceso : suministro de medicamentos confiables de alta calidad independientemente de la geografía o las circunstancias; Liderazgo : promover operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente; Asociación : aprovechando nuestra experiencia colectiva para conectar a las personas con productos y servicios. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world. The Role & What You Will Be Doing The Quality Operations (QO) Systems Senior Manager leads and manages the QO Systems team. The team has responsibility for the implementation of new QC systems and maintaining the existing laboratory systems at Viatris Little Island. The role incorporates responsibility in the areas of laboratory systems and applications; implementation, compliance, LIMs template builds, budgeting, and resourcing. The QO Systems Senior Manager will proactively manage the team to ensure laboratory systems are maintained according to Viatris cGMP standards and seeks opportunities for improvement. Every day, we rise to the challenge to make a difference and here’s how the Senior Manager, Quality Operations Systems role will make an impact:- Ensure all QC IT systems are adequately validated and compliant with GMP requirements.
- Responsibility for laboratory systems, including but not limited to gLIMS, SAP interface, MODA, Empower, NuGenesis.
- Ensure all equipment is calibrated in accordance with the calibration schedule.
- Perform periodic review of QC IT systems in line with Corporate IT policies.
- Site SME for Data Integrity and support cross site DI forums as required.
- Perform access reviews, restore reviews to ensure systems meet all DI requirements.
- Adequately train and ensure all users are assigned correct security profiles.
- Provide Operational support /troubleshooting for QC IT systems to ensure batch release is maintained in line with value stream and customer requirements.
- Focus on CI projects that will deliver benefits to all system users.
- Ensure maximum up-time for all systems and breakdowns/repairs are resolved as soon as possible.
- Maintain vendor service contracts for QC IT systems and applications where applicable.
- Install and validate lab instrumentation as required and in line with site safety and quality requirements.
- Ensure LIMS builds are completed as required to meet Production schedule.
- Strategic direction for QC IT systems and system infrastructure – planning for the future.
- Bachelor of Science Degree in chemistry, engineering, or another related discipline.
- 5+ years of experience in a cGMP laboratory environment.
- People management experience or genuine interest in managing a team.
- Experience with building master data and templates.
- In-depth technical knowledge of LIMS and LIMs master data.
- Demonstrated thorough knowledge of all aspects of laboratory IT systems and applications.
- Demonstrated ability to achieve results.
- Demonstrated ability to cope with complexity and changing environments.
- Ability to extract data from QC systems and generate reports (e.g., Minitab, Cognos).
- Excellent career progression opportunities
- Work-life balance initiatives
- Bonus scheme
- Health insurance
- Pension
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