Overview
On Site
Full Time
Skills
Risk Assessment
Training
IQ
OQ
PQ
GDP
Regulatory Compliance
Software Testing
Risk Management
Standard Operating Procedure
Configuration Management
Auditing
Process Improvement
Computer Science
Computerized System Validation
Pharmaceutics
Software Quality Assurance
Software Development Methodology
Change Management
Documentation
Verification And Validation
Project Management
Leadership
Quality Audit
GMP
Medical Devices
Quality Assurance
ISO 9000
GAMP
Quality Management
Document Management
Management
Job Details
Responsibilities:
- Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments).
- Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans.
- Providing leadership, oversight, and training related to validation activities to multi-functional teams.
- Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentation Practices (GDP).
- Ensuring that the quality system elements necessary to achieve and maintain compliance across multiple businesses, including regulated environments, are established and activities related to computer systems/software testing are controlled via these elements.
- Working with appropriate teams to establish quality expectations related to validation planning and execution.
- Participating with stakeholders in the preparation of software specification documents, risk management and validation plans.
- Participating in developing qualification processes and implementing standard operating procedures.
- Participate in execution of gap assessment and remediation activities.
- Investigate and resolve exceptions, non-conformances, deviations, CAPAs and change controls related to validation protocols.
- Authoring, reviewing, and/or approving system change, configuration management and supporting documentation activities.
- Preparing for and participating in external/internal computer system/software audits.
- Serve as the SME for CSV activities and maintain knowledge and information in the CSV area of expertise.
- Contributing to process improvements by developing and updating written procedures related to computer systems.
- Bachelor's/master's degree in computer science engineering or equivalent.
- At least 10 years of experience in Computer System Validation role in the pharmaceutical, biotech, medical device, or other regulated industry.
- Demonstrated experience in software quality assurance processes, SDLC methodology, change management, documentation, verification, and validation techniques.
- Understanding of GAMP 5 techniques and software industry standards and their impact on internal procedures, and software quality.
- Demonstrated project management and leadership skills.
- Proficiency in interacting with contacts, including project teams and vendors.
- Certified auditor or equivalent experience conducting software-vendor quality audits.
- Working knowledge of the FDA Quality System Regulation, 21 CFR Part 11, EU GMP, Annex 11 and the European and Canadian Medical Device Directives.
- Understanding of current software quality techniques and industry standards such as ISO, ASQ, AAMI, and GAMP.
- Quality Management System.
- Document Management System.
- Validation Management System.
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