What are the responsibilities and job description for the CSV Consultant position at Katalyst CRO?
Job Description
The Program CSV Consultant will provide strategic guidance and oversight during the planning and setup of CSV deliverables for the client's Foundry Program.
Responsibilities
The Program CSV Consultant will provide strategic guidance and oversight during the planning and setup of CSV deliverables for the client's Foundry Program.
Responsibilities
- Interface with client Subject Matter Experts, Site and Area Management, Quality Assurance, and other stakeholders for validation planning.
- Guide the creation and updates of project validation planning deliverables such as Validation, Security, and Test Plans.
- Support execution of validation activities in alignment with the approved Validation Plan and CSV documentation standards.
- Assist Project CSV Leads in generating/editing CSV documents and electronic testing templates.
- Recommend improvements to ensure compliance and consistency across all CSV deliverables.
- Support creation of reports, dashboards, and queries within change management, document management, and electronic test systems.
- Provide mentoring and guidance to SMEs and project team members.
- Promote a culture of reliability and compliance within CSV processes.
- Collaborate closely with Quality Assurance personnel to ensure alignment with quality and compliance expectations.
- Support onboarding, training, and workload management for validation personnel.
- Anticipate future validation needs and trends to maintain system compliance.
- Bachelor's degree in engineering or equivalent.
- Minimum 10 years of experience in CSV within the pharmaceutical industry.
- Proven experience in large-scale pharmaceutical automation or program environments.
- Hands-on experience with Kneat electronic test management systems.
- Proficiency in Microsoft Office and web-based documentation tools.
- Strong collaboration, communication, and documentation skills.
- Prior exposure to electronic document management systems preferred.