Beschreibung
Systems Validation Specialist - Pharma, Manufacturing/quality assurance processes and systems, CSV, GxP, FDA 21 CFR part 11, HIPAA, SaMD, Data PrivacyRole:
For our client in the Pharma industry based in Kaiseraugst / Basel we are looking for a Systems Validation Specialist. 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? Then Personalized HealthCare (PHC) is looking for you! 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. At Genentech we are accelerating the use of data insights and digital technologies to make significant strides to reach the full potential of personalized healthcare.
As a PHC Informatics (IX) Compliance BSA, you will join our diverse PHC IX community of smart, fun, wholehearted, and engaged professionals from various functional areas. You will share our community values of passion, courage, integrity, and gratitude -- all in service of our mission, "doing now what patients need next." Your primary accountability is to provide quality leadership. By being deeply engaged with our 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 lifecycle. As a PHC IX Compliance BSA, you will establish strong relationships and manage stakeholders across the globe. You are someone who can negotiate and influence at all levels.
Areas of responsibility:
- 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.
Professional and technical requirements:
- BA or BS in life science, informatics, business, or equivalent. MA or MS and post-graduate
coursework is 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
- Proven skills in relationship building, customer-focus, decision-making, and problem solving.
- Demonstrated ability to quickly learn business priorities in unfamiliar or ambiguous areas.
Reference no: 919700 AD
Role: Systems Validation Specialist
Industry: Pharmaceutical industry
Workload: 100%
Location: Kaiseraugst / Basel, Switzerland
Start date: 16.10.2020 Latest start date: 02.11.2020 Duration: 9 months contract, with possible extension
About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.