Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
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.
Project Management:
- 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.
Compliance & Expertise:
- 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.
Requirements:
- 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.