Job
Description
Job Summary: You will be responsible for overseeing and managing the validation processes of systems, processes, or products to ensure compliance with industry standards and regulations. Your role will involve extensive experience in system validation, quality assurance, and compliance management, with a focus on meeting regulatory requirements and ensuring operational efficiency. Key Responsibilities: - Lead and manage system validation activities for projects to ensure compliance with relevant regulatory standards such as FDA, GMP, ISO, and 21 CFR Part 11. - Develop and execute validation plans, protocols (IQ, OQ, PQ), and reports for systems and processes. - Coordinate with cross-functional teams (IT, Engineering, Quality Assurance) to ensure validation requirements are met and maintained throughout the system lifecycle. - Identify, assess, and mitigate risks related to system validation processes. - Review and approve validation documentation, ensuring regulatory and internal standards are met. - Ensure proper documentation and traceability for all validation activities, including deviations and corrective actions. - Manage the implementation and maintenance of validated systems to ensure ongoing compliance. - Act as the primary point of contact for all validation-related queries and issues, providing guidance and expertise. - Conduct impact assessments for changes to validated systems or processes and ensure appropriate re-validation is performed. - Collaborate with stakeholders to align validation activities with business needs and project timelines. - Monitor and report on the status of validation projects and activities, highlighting any issues or delays to senior management. - Provide training and support to internal teams on validation methodologies, processes, and best practices. - Support audits and inspections by regulatory agencies, providing necessary validation documentation and addressing findings. Required Skills & Qualifications: - Bachelor's degree in Life Sciences, Engineering, Information Technology, or a related field. - Proven experience as a Validation Consultant or in a validation role within regulated industries (Pharmaceuticals, Biotech, Medical Devices, IT). - In-depth knowledge of industry regulations and standards, including GxP, 21 CFR Part 11, and ISO 13485. - Experience in writing and executing validation protocols (IQ, OQ, PQ) and validation reports. - Strong project management skills, ability to lead validation efforts, coordinate resources, and meet deadlines. - Strong analytical and problem-solving skills, ability to identify issues and propose corrective actions. - Excellent communication skills, both written and verbal, ability to interact effectively with various stakeholders. - Knowledge of risk-based validation approaches and best practices. - Proficiency with validation tools and systems is a plus. Preferred Qualifications: - Certification in Validation or Quality Management (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). - Prior experience with regulatory inspections and audit preparation (FDA, EMA, ISO audits).,
