Katalyst Healthcares and Life Sciences
Validation (CSV) Project Manager
Katalyst Healthcares and Life Sciences, San Mateo, California, United States, 94409
Responsibilities:
Project Planning: Develop comprehensive project plans for validation activities, outlining scope, timelines, resources, and deliverables. Collaborate with cross-functional teams to ensure alignment with project goals.GMP Compliance: Ensure all validation processes adhere to GMP guidelines and other relevant regulatory standards. Stay updated on changes in regulatory requirements and communicate them to the project team.Equipment and Process Validation: Oversee the validation of manufacturing equipment and processes to ensure compliance with GMP and quality standards. Develop and execute validation protocols and reports.Qualification and Validation Documentation: Manage the creation, review, and approval of qualification and validation documentation, including validation plans, protocols, and summary reports.Change Control: Implement and manage change control processes related to validated systems and processes. Ensure that changes are assessed, documented, and validated as required.Risk Management: Identify and manage risks associated with validation projects, implementing mitigation strategies as necessary.Mandatory - 21CFR, GMP, CSV
Project Planning: Develop comprehensive project plans for validation activities, outlining scope, timelines, resources, and deliverables. Collaborate with cross-functional teams to ensure alignment with project goals.GMP Compliance: Ensure all validation processes adhere to GMP guidelines and other relevant regulatory standards. Stay updated on changes in regulatory requirements and communicate them to the project team.Equipment and Process Validation: Oversee the validation of manufacturing equipment and processes to ensure compliance with GMP and quality standards. Develop and execute validation protocols and reports.Qualification and Validation Documentation: Manage the creation, review, and approval of qualification and validation documentation, including validation plans, protocols, and summary reports.Change Control: Implement and manage change control processes related to validated systems and processes. Ensure that changes are assessed, documented, and validated as required.Risk Management: Identify and manage risks associated with validation projects, implementing mitigation strategies as necessary.Mandatory - 21CFR, GMP, CSV