Related skills
machine learning gxp lims eln 21 cfr part 11📋 Description
- QA oversight of computer validations and equipment qualifications.
- Collaborate with cross-functional teams to meet business needs.
- Author validation docs for new and existing systems.
- Plan and complete validation projects for LIMS, ELN, and software.
- Collect requirements for risk-based validation.
- Investigate issues and implement corrective actions.
🎯 Requirements
- Bachelor’s degree in engineering, science, or related discipline.
- 5+ years in pharmaceutical/GxP/regulatory environment.
- Hands-on validation for lab computer systems and equipment.
- Experience with GxP regs (FDA, EU, ICH, USP, ISO).
- Knowledge of GAMP guidelines and lifecycle principles.
- IT infrastructure and database systems knowledge.
- Strong written and verbal communication; MS Office skills.
🎁 Benefits
- Medical, dental, vision insurance
- Flexible Spending Account (FSA)
- Short/long-term disability and life insurance
- Paid time off and parental leave
- Paid holidays
- 401(k) with employer match
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