Job Description
Computer System Validation
Newark, CA (Onsite)
6 months contract
Top 3 Skills – Lab
System Validation
Computer System Validation
Lab
System Instrument
Job Summary
The incumbent will be a part of the IT Computerized System Validation (CSV)
Department and will perform and/or direct GxP computerized system validation
projects in compliance with cGMP, 21 CFR Part 11 and Annex 11. This individual
will ensure that GxP systems meet intended uses and comply with applicable
regulations, current industry practices, and Revance’s policies and procedures.
Validation projects may primarily include Lab systems and Steady-state
activities around these systems.
Essential Duties/Responsibilities
- Provide independent
technical leadership and accountability for overall computer system
validation efforts.
- Ensure quality and
compliance in accordance with established procedures and standards of the
Quality Systems by applying critical thinking on CSV work
- Generate, review and
approve base level document such as Validation Plan, URS, FRS, DS, and
SOPs in support of Computerized System Validation/Assurance activities
- Generate, review/approve
and executing computer validation (IQ, OQ, and PQ) documentation for GxP
systems from Quality Control Units
- Develop, implement and
maintain computer system validation-related controlled documents to
support the initiation, validation, operation and maintenance of GxP
systems.
- Assist with change
controls, CAPAs, deviations, exceptions required as part of system
validation efforts
- Support system
administrative & maintenance activities for Lab Systems
- Support continuous
improvement efforts by monitoring, tracking and performing the steady
state activities for Lab Systems
- Perform gap analysis
& necessary remediation efforts on current computer systems to ensure
compliance with Part 11 and Annex 11.
- Collaborate/lead/participate
in decision-making and make recommendations regarding the best options for
validation of computer systems. Maintain close communication with
stakeholders and team members to keep apprised of computer system needs,
impact on computer system validation, project validation status, and other
relevant issues
- Collaborate with
Revance-approved vendor personnel in coordinating validation efforts
including reviews/approvals of related validation deliverables and for
ensuring a successful validation lifecycle.
- Reviews
department-specific SOPs periodically and updates if/as needed to ensure
that the procedures are always up to date based on the latest regulatory
updates and industry best practices.
- Perform system
assessments based on version upgrades/release updates on SaaS/Cloud-based
GxP systems and ensure all the required verification and validation
efforts are performed per the assessments conducted.
- Facilitate the computer
system validation risk assessments i.e. System level, Requirement level
risk assessments, & System and Data Audit Trail assessments, etc.
- Develop or assist with
business process deliverables such as process flows, data flows,
user/operating procedures, work instructions and forms for GxP
computerized systems.
- Perform Periodic System
Reviews ensuring that the systems maintain their validated status
- Support Regulatory
inspections and internal and partner audits, and implements corrective
actions as needed in CSV
Education
Minimum Required: Bachelor's degree in Engineering, Science or a related
technological field
Preferred: Bachelor’s degree in Pharmaceutical Science, Biomedical Engineering,
or Management of Information Systems (MIS).
Experience
Minimum Required:
- Minimum of Six (6-8)
years or more in the pharmaceutical industry with GMP experience.
- Understanding phases of
Life Cycle Validation approach and practical working knowledge of computer
system validation/computer software assurance requirements.
- Knowledge of validation
of cGMP automation/computerized systems within an FDA regulated
environments with a strong understanding of industry standards and best
practices for computer validation such as GAMP 5, 21 CFR Part 11 and Part
211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10.
- Demonstrate ability to
effectively manage multiple projects/priorities
- Demonstrate excellent
written and oral communication skills.
- Effective time
management and interpersonal skills.
- Must work effectively
within teams with rapidly changing priorities.
- Demonstrates analytical
problem-solving skills.
Preferred:
Relevant validation experience with Laboratory systems used within the
pharmaceutical industry is a plus.
Knowledge, Skills and Abilities
Minimum Required: Risk Management Tools, MS Word, Excel, PowerPoint, Visio,
Project and Outlook.
Preferred: TOC Analyzer, LCMS-Sciex, Novatek LIMS, ValGenesis VLMS
Keywords:
Education:
Skills and Experience:
Required Skills:
- AUDIT
- LIFE CYCLE
- FDA
- SYSTEM VALIDATION
- CGMP
Additional Skills:
- GMP
- RISK ASSESSMENTS
- ICH
- GAP ANALYSIS
- SAAS
- DOCUMENTATION
- TECHNICAL LEADERSHIP
- MAINTENANCE
- SOPS
- REMEDIATION
- SYSTEM LEVEL
- SOFTWARE AS A SERVICE
- COMPUTER VALIDATION
- GXP
- QUALITY CONTROL
- INSPECTIONS
Job Tags
Full time, Contract work,