Beschreibung
Systems Validation Specialist (m/f/d)
Reference: -en
Start: 10/20
Duration: 9 MM+
Main tasks:
- Concurrently manage multiple projects of diverse scope across functional areas
- Manage and deliver projects using agile and waterfall methodologies
- Able to articulate and facilitate the understanding of a system’s intended use and it’s compliance risk profile.
- Risk-based identification and classification of GxP systems
- Guide software project and product teams in understanding their role in establishing and maintaining the compliance of critical systems.
- Drive simplification and transparency across the organization
- Leverage the technical expertise of the internal teams and external technology providers and vendors to deeply understand the risk.
- Characterize for compliance purposes as-built and vendor provided business solutions that may involve automated systems and/or modifications to business processes.
- Engage with Procurement on acquisitions and assess compliance against internal expectation and SOPs’
- Assess outsourced vendors and clinical suppliers.
- Be a trusted partner for the Global Privacy Office, IT Security, and Business Qualityteams
- Maintain an expert-level knowledge of the dynamic health authority governance; inclusive of GDPR, CCPA, HIPAA, SaMD, 21 CFR part 11, Article 11.
- Be accountable for documentation, which may include, but is not limited: System Risk Assessments, Data Classification Reports, User Requirements, Validation Plans, Validation Reports, Validation Registries, Requirements Traceability Matrices, Test Plans, Test Reports, Functional and/or technical specifications, Data and process flow diagrams, Training documentation and/or work instructions, Other Computer System Validation documents and related systems, Drive resolution of business or systems issues.
Main qualifications
- BA or BS in life science, informatics, business, or equivalent. MA or MS and post-graduate coursework are desirable
- Profound related experience, domain knowledge of the pharmaceutical industry and manufacturing/quality assurance processes and systems, computer systems validation, GxP, FDA 21 CFR part 11, HIPAA, SaMD, Data Privacy
- Experience in a technology role IT or Data
- Program or IT Project management experience
- Expert knowledge of Software Development Life Cycle methodologies, inclusive of Agile
- Experience leading cross-functional collaborative team environments, provide innovative solutions to complex business problems and make decisions with cross-functional impact
- Strong English and German communication skills (nice to have) -- ability to communicate complex information, issues, and potential solutions at an executive level
- Proven skills in relationship building, customer-focus, decision-making, and problem solving
- Demonstrated ability to quickly learn business priorities in unfamiliar or ambiguous areas
Main advantages:
- You will work in an international environment
- A very renowned company
About us:
IT specialists hold all the cards: for its customers in industry and the public sector, Hays is looking for motivated employees who like looking at the bigger picture and growing with new challenges. We make sure that you benefit from our many years of experience in IT recruitment and will find you the right role to suit your skills and interests – all completely free of charge to you. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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