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Catalent Pharma Solutions
,
Bathgate, West Lothian
CSV Quality Specialist
Overview
Job Description
Position Overview: Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents , ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here The Quality Specialist for IT Systems and Computer System Validation (CSV) is a member of the Central Quality team and is responsible for supporting the infrastructure and processes for Good Manufacturing Practice (GMP) /Regulatory compliance within Catalent Pharma Solutions. This position focuses on the full system life cycle and supporting processes for global laboratory, manufacturing, packaging, quality and regulatory affairs systems across Catalent. The new hire will report to the Quality Manager, IT Systems / CSV who is based in Kansas City, Missouri site. The primary responsibility for the Quality Specialist for IT Systems and CSV is providing Quality oversight, guidance and support to global teams and sites to facilitate compliance with current regulatory requirements, Catalent policies, applicable GxP and data integrity. This role requires the development of good working relationships with global, site, supplier and key customer quality functions. This position works closely with the project teams, suppliers, site quality and IT teams serving as an expert quality and compliance resource, bringing forth opportunities for the implementation of new world-class systems and leveraging existing systems to help support the growth of the business. The Role/Job Duties: * Quality oversight of the design, development, validation, implementation and ongoing maintenance and use of computerised GxP systems and IT infrastructure. Also, quality oversight of assessments, change controls, periodic reviews, investigations, deviations and CAPAs relating to computerised GxP systems. * Compliance support to global teams and sites as a subject matter expert. * Provide data integrity program management, oversight and training for global teams, systems and sites. * Identify compliance and process improvements based upon internal and external audit observations and regulatory surveillance. * Collaborate on the development and maintenance of Global Quality and CSV Polices, Standards and Procedures as well as participate in associated roll out and training. * Participate in internal and supplier audits as a compliance, IT and CSV subject matter expert. Support regulatory and client audits of Catalent global systems and sites. The Candidate Education and Experience: * Bachelor's Degree in Information Technology, Engineering, pharmaceutical sciences or related fields. * 3 to 5 years within the pharmaceutical, life sciences or related industry. 3 years in an IT, quality, regulatory or related operational role. * Ability to travel domestically and internationally up to 25% * Experience with teams in a global multi-site environment. Fluency in a non-English languages a plus. Knowledge/Skills Requirements: * Working knowledge of various pharmaceutical laboratory, manufacturing, packaging and quality systems and business processes (e.g., Empower 3, laboratory instrument systems, LIMS, Scada, Serialization, Trackwise, Documentum, ERP). * Working knowledge of applicable regulatory and industry guidance on GxP systems development, implementation, validation, maintenance, ongoing use and data integrity. * Working knowledge of computer infrastructure, servers, workstations, operating systems, databases. * Manage time and workload in a fast-paced, high-volume, multi-tasking work environment with limited supervisory guidance. * Professional with strong organisational, interpersonal, communication, presentation and problem-solving skills. * Confidently interact with personnel at all levels of the organisation from a variety of cultural backgrounds and manage/develop strategic relationships with suppliers and external partners. * Strong analytical, creative and critical thinking capabilities. Self-starter with the ability to work independently in an office, remote or non-office environment. Team player that is respectful of others, can work with and through others on cross-functional teams, can hold team members accountable and ensure compliant outcomes. We will identify candidates based on the following: * Leads with Integrity and Respect * Delivers Results * Demonstrates Business Acumen * Fosters Collaboration and Teamwork * Champions Change * Engages and Inspires * Coaches and Develops Position Benefits: * Join a high growth and fast paced organisation with a people focused culture * Global exposure, defined career path and annual performance review and feedback process * Compe