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Sr. Validation Specialist, IT - Los Angeles, United States - BioPhase Solutions
Description
Job DescriptionJob Description
BioPhase Solutions
specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a
Sr. Validation Specialist, IT
to work for a leading Greater Los Angeles area biopharmaceutical company.
Salary:
$110-130k depending on experience
Summary:
The Sr. Validation Specialist is responsible for compliance oversight of enterprise CSV projects as part of the IT team. This role is hands-on, highly cross-functional, and works closely with various business stakeholders to ensure GxP compliance. Supports validation of all Manufacturing, R&D, and Quality Systems. Coordinates and/or supports delivery of compliance deliverables such as System Inventory, Quality Impact Assessments, Data Integrity Assessment, Risk Assessments, Gap Analysis, System Remediation, System Change Control and CAPA
investigations/resolutions.
**
Note**
Local candidates only
This position will require an on-site presence on
occasion/emergencies.
However, the position can be remote.
Responsibilities:
Oversee the execution of
qualification/validation
activities new software implementations and maintenance of existing systems.
Author, review and approve
qualification/validation
documentation (specifications, protocols, risk assessments, reports).
Perform risk assessments with functional teams to assess system risks and develop mitigation plans
Update and/or create computer system related policies, procedures, templates, forms, etc.
Provide input to GxP assessments for 21 CFR Part 11 requirements
Oversee the execution of
qualification/validation
activities new software implementations and maintenance of existing systems.
Author, review and approve
qualification/validation
documentation (specifications, protocols, risk assessments, reports).
Perform risk assessments with functional teams to assess system risks and develop mitigation plans
Update and/or create computer system related policies, procedures, templates, forms, etc.
Provide input to GxP assessments for 21 CFR Part 11 requirements
Review and approve computer system change controls, discrepancies, CAPAs
Review and provide feed to vendor validation documentations (Validation plan, executed protocols, risk assessments)
Works closely with the QA function to provide expertise in CSV compliance, manage identified issues, and support continuous improvement.
Support inspection readiness programs and/or directly support regulatory agency inspections. Assist in the coordination of response to any findings as applicable.
Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations.
Requirements:
Minimum of a bachelor's degree in engineering, science or equivalent technical discipline is required.
Minimum 5+ years of experience working in
biotech/pharmaceutical
industry in Quality compliance or Computer System Validation role.
Strong knowledge in CFR 21 Parts 11, GAMP5, electronic record/electronic signature, and data integrity requirements, standards and guidelines.
Strong background and understanding of FDA regulations.
Knowledge of Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).
Experience inauthoring/reviewing/approving
validation documentation.
Working knowledge of software development lifecycle (SDLC).
Experience supporting enterprise software deployments, ERP, DMS, QMS, etc.
Excellent written and verbal communication skills ability to work with cross-functional teams.
Experience with vendor audits, quality agreements
Ability to manage multiple projects
Please send resumes to
and visit our website at
for additional job opportunities
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