Job
Description
Job Purpose JOB DESCRIPTION To ensure compliance of computerized systems, PLC/SCADA-controlled equipment, and automation systems with regulatory requirements (21 CFR Part 11, EU Annex 11, GAMP 5, etc.) by executing validation activities as per approved procedures and maintaining validated states throughout the system lifecycle. Key Responsibilities Validation Planning & Execution: Develop and maintain validation protocols (URS, DQ, IQ, OQ, PQ, RTM) for computerized systems and PLC/SCADA-controlled equipment. Execute validation activities in line with cGMP, GAMP 5, and internal SOPs. Review and approve vendor-supplied documentation (FDS, HDS, SDS, FAT/SAT, etc.). Compliance & Documentation Ensure systems comply with 21 CFR Part 11 and data integrity principles. Maintain proper documentation and traceability of all validation activities. Prepare validation summary reports and maintain system validation status. Risk Assessment & Change Management Conduct risk assessments for new or modified systems and automation projects. Participate in impact assessments and manage change control for validated systems. Audit Support & Training Support internal and external audits (USFDA, MHRA, EU, WHO, etc.). Provide training and guidance to users and departments on validated systems and data integrity practices. Coordination & Vendor Management Coordinate with Engineering, IT, QA, QC, Production, and vendors for validation-related activities. Monitor vendor performance and ensure timely completion of qualification activities. Lifecycle Management Ensure systems remain in a validated state through periodic reviews and re-validation as needed. Support decommissioning and archival activities as per SOPs. Key Skills And Competencies Strong knowledge of CSV principles, GAMP 5, 21 CFR Part 11, and Annex 11. Familiarity with PLCs, SCADA, HMI, DCS, MES, and Building Management Systems (BMS). Understanding of pharmaceutical manufacturing processes and regulatory requirements. Good documentation, analytical, and problem-solving skills. Effective communication and project coordination abilities. Qualifications Qualification: B.Pharma/ M.Pharma/ B.E / B.Tech Candidate must have 3 - 5 years of relevant experience. Note: Employee who want to apply for internal job posting must have completed atleast 2 years in his current role. Show more Show less
