Job
Description
Role Overview: As a GxP Validation and Compliance Specialist at micro1, you will play a crucial role in ensuring risk-based validation and regulatory compliance for computer and automated systems within a dynamic on-site environment. Your expertise in computer system validation (CSV/CSA) and GxP regulations will be utilized to maintain robust, audit-ready documentation and controls for electronic records and signatures. Your contributions will shape quality standards and regulatory adherence across various business-critical operations. Key Responsibilities: - Lead and execute risk-based validation strategies for computer and automated systems in compliance with GxP requirements. - Develop, review, and maintain validation protocols, reports, and life cycle documentation following CSV/CSA best practices. - Ensure compliance with relevant regulatory frameworks such as FDA, EMA, MHRA for electronic records and electronic signatures (ER/ES). - Design, implement, and review audit trails for critical systems to ensure data integrity and traceability. - Support and prepare for regulatory inspections and internal/external audits by maintaining thorough documentation and readiness. - Provide expert guidance on deviation management, CAPA, and change control processes for GxP-related systems. - Collaborate cross-functionally to drive continuous improvement and knowledge sharing on validation and compliance topics. Qualifications Required: - Demonstrated proficiency in risk-based computer system validation (CSV) and/or computer software assurance (CSA). - In-depth knowledge of regulatory requirements for GxP, including 21 CFR Part 11, Annex 11, and associated guidance. - Hands-on experience with audit trail design and management in a regulated environment. - Proven expertise in electronic records and electronic signatures (ER/ES) compliance. - Exceptional written and verbal communication skills, with a strong focus on accuracy and clarity. - Excellent organizational skills with the ability to manage multiple projects and deadlines. - Strong problem-solving mindset, attention to detail, and a proactive approach to compliance challenges. Note: No additional details about the company were provided in the job description. Role Overview: As a GxP Validation and Compliance Specialist at micro1, you will play a crucial role in ensuring risk-based validation and regulatory compliance for computer and automated systems within a dynamic on-site environment. Your expertise in computer system validation (CSV/CSA) and GxP regulations will be utilized to maintain robust, audit-ready documentation and controls for electronic records and signatures. Your contributions will shape quality standards and regulatory adherence across various business-critical operations. Key Responsibilities: - Lead and execute risk-based validation strategies for computer and automated systems in compliance with GxP requirements. - Develop, review, and maintain validation protocols, reports, and life cycle documentation following CSV/CSA best practices. - Ensure compliance with relevant regulatory frameworks such as FDA, EMA, MHRA for electronic records and electronic signatures (ER/ES). - Design, implement, and review audit trails for critical systems to ensure data integrity and traceability. - Support and prepare for regulatory inspections and internal/external audits by maintaining thorough documentation and readiness. - Provide expert guidance on deviation management, CAPA, and change control processes for GxP-related systems. - Collaborate cross-functionally to drive continuous improvement and knowledge sharing on validation and compliance topics. Qualifications Required: - Demonstrated proficiency in risk-based computer system validation (CSV) and/or computer software assurance (CSA). - In-depth knowledge of regulatory requirements for GxP, including 21 CFR Part 11, Annex 11, and associated guidance. - Hands-on experience with audit trail design and management in a regulated environment. - Proven expertise in electronic records and electronic signatures (ER/ES) compliance. - Exceptional written and verbal communication skills, with a strong focus on accuracy and clarity. - Excellent organizational skills with the ability to manage multiple projects and deadlines. - Strong problem-solving mindset, attention to detail, and a proactive approach to compliance challenges. Note: No additional details about the company were provided in the job description.
