System Validation Specialist
Posted on Sep 23, 2020 by Coopers Group GmbH
For our Pharma Client in Basel, we are currently looking for a
Systems Validation Specialist
Location: Basel area
Contract type: temporary contract
Start/Ende: 16.10.2020 - 9 months contract
Are you a strong Business Systems Analyst with demonstrated experience on multiple projects who is looking for a creative, challenging and fun work environment and an opportunity to expand your skills?
The power of data at scale has transformed almost every industry, personalizing experiences in many aspects of our lives. Yet in healthcare, we've only scratched the surface. Our Client is accelerating the use of data insights and digital technologies to make significant strides to reach the full potential of personalized healthcare.
Your primary accountability is to provide quality leadership. By being deeply engaged with the business partners, you will develop a strong understanding of safety, clinical and medical data; you are driving design, creation, and adoption of novel validation strategies, ensuring data integrity and privacy to teams across the product development life cycle. As a BSA, you will establish strong relationships and manage stakeholders across the globe. You are someone who can negotiate and influence at all levels.
Tasks & Responsibilities:
- 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
- Manage compliance documentation processes including, but not limited to, System Risk Assessments (SRA) and Data Classification Reports (DCRs)
- Leverage the technical expertise of the internal teams and external technology providers and vendors to deeply understand the risk.
- Manage vendor 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 to:
- 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.
- BA or BS in life science, informatics, business, or equivalent. MA or MS and post-graduate coursework are desirable
- At least 10 years of 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
- 3+ years 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