Overview
On Site
Full Time
Skills
Risk Assessment
GxP
Project Management
Communication
Project Delivery
Collaboration
Documentation
Auditing
Quality Assurance
Quality Management
Regulatory Compliance
Computerized System Validation
GAMP
Veeva
ServiceNow
JIRA
Pharmaceutics
Management
Job Details
Responsibilities:
Documentation & Deliverables:
Documentation & Deliverables:
- Develop and author comprehensive validation and quality documentation, including protocols, reports, risk assessments, SOPs, and other project-related materials.
- Ensure all documentation complies with applicable regulatory standards such as FDA, EMA, GxP, and other relevant guidelines.
- Review and approve validation documents to confirm alignment with both project objectives and regulatory requirements.
- Lead and oversee multiple quality and validation projects, ensuring clear communication of goals, timelines, and key milestones.
- Proactively identify potential risks and implement mitigation strategies to ensure timely and successful project delivery.
- Collaborate with internal teams and external stakeholders to ensure alignment on deliverables and expectations.
- Conduct regular project status meetings and prepare progress reports for stakeholders.
- Ensure all validation activities and documentation adhere to industry best practices and regulatory requirements.
- Provide support during internal and external audits by offering expertise in validation and quality assurance.
- Serve as a subject matter expert in quality systems, validation methodologies, and regulatory compliance.
- IT CSV - Validation of IT systems.
- CQV - Qualification of Equipment.
- Knowledge of regulatory frameworks (e.g., FDA 21 CFR Parts 11, 211, 820; along with industry standards (e.g., ISPE, GAMP 5).
- Experience with Veeva Quality Docs, ServiceNow, JIRA and Kneat.
- Pharma industry experience is mandatory.
- Experience in authoring validation documents and managing validation projects.
- Lead and oversee multiple quality and validation projects.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.