Sr. Validation Specialist, IT
BioPhase Solutions
Los Angeles, CA
- $110 Hourly
- Full-Time
Job Description
Company Info
Job 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 in authoring/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 gavin@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!
How can the hiring manager reach you?
You Already Have an Account
We're sending an email you can use to verify and access your account.
If you know your password, you can go to the sign in page.