Validation Compliances Gxp Consultant

Job Summary: As a Validation Compliance GxP Consultant, you will be responsible for overseeing and managing the validation processes of systems, processes, or products to ensure compliance with industry standards and regulations. You should have extensive experience in system validation, quality assurance, and compliance management, with a focus on meeting regulatory requirements and operational efficiency. Key Responsibilities: You will lead and manage system validation activities for projects to comply with regulatory standards such as FDA, GMP, ISO, and 21 CFR Part 11. Developing and executing validation plans, protocols (IQ, OQ, PQ), and reports for systems and processes is a key part of your role. You will collaborate with cross-functional teams to ensure validation requirements are met throughout the system lifecycle and identify, assess, and mitigate risks related to validation processes. Ensuring that all validation documentation meets regulatory and internal standards, maintaining proper documentation and traceability for all validation activities, managing the implementation and maintenance of validated systems, and acting as the primary point of contact for validation-related queries and issues are also part of your responsibilities. You will conduct impact assessments for changes to validated systems, align validation activities with business needs and project timelines, monitor and report on validation projects" status, and provide training and support to internal teams on validation methodologies, processes, and best practices. Required Skills & Qualifications: A Bachelor's degree in Life Sciences, Engineering, Information Technology, or a related field is required. You should have proven experience as a Validation Consultant or in a validation role within regulated industries such as Pharmaceuticals, Biotech, Medical Devices, or IT. In-depth knowledge of industry regulations and standards like GxP, 21 CFR Part 11, and ISO 13485 is essential. Experience in writing and executing validation protocols (IQ, OQ, PQ) and reports, strong project management skills, analytical and problem-solving skills, excellent communication skills, and knowledge of risk-based validation approaches and best practices are also necessary. Proficiency with validation tools and systems is a plus. Preferred Qualifications: Certification in Validation or Quality Management (e.g., CQE, CVP), experience with automated systems validation and cloud-based platforms, familiarity with electronic records and electronic signatures (21 CFR Part 11) and computer system validation (CSV), and prior experience with regulatory inspections and audit preparation are preferred qualifications for this role.,