IT Compliance Lead
Company: Vericel Corporation
Posted on: November 23, 2022
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Accountable for delivering validation knowledge leadership for IT
projects by creating computerized systems life cycle documentation,
creating and revising IT standard operating procedures and
deploying technology solutions to ease the administrative burden in
a compliant manner.ESSENTIAL FUNCTIONS
- Develop solutions (knowledge base, artifacts, technology) to
address IT Quality Compliance needs.
- Deliver agility to the organization by streamlining IT Change
Management and CSV processes.
- Draft Computer Systems Validation and IT Change Management SOPs
to align with GAMP 5 and industry standards.
- Author, review and update validation documents as necessary for
GxP IT implementation projects.
- Provide Delivery Support to multiple ongoing IT
- Evaluate business requirements and provide solutions based on
- Provide expertise in the areas of IT Quality & Compliance,
Computer Systems Validation, Quality assessments, ISO 13485
regulations, 21 CFR Part 11, Annex 11, GxP requirements, Quality
System Regulations, CAPA processes, Quality Management Systems
design, Supply chain management, process validation and Quality
system validation for regulated Life Science
environments.QUALIFICATIONS, EDUCATION AND EXPERIENCEBasic
- MUST have Pharmaceutical, Bio-Technology, or Life Science
- 7+ years of experience in Computer System Validation in a cGMP
- Knowledge of GMPs, GAMP 5, 21 CFR Part 11, Annex 11, MHRA/FDA
Keywords: Vericel Corporation, Cambridge , IT Compliance Lead, Other , Cambridge, Massachusetts
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