Contract Staff - Computer System Validation

Role & responsibilities

Job Summary:

Supporting of CSVC validation activities in collaboration with IS, Business users of ARPL and APIPL under the guidance of senior CSVC personnel.

Preferred candidate profile

• Experience - 0 to 1year
• Contract Tenure : 2Yrs (Based on performance final decision would be taken Post 2yrs of completion/ Extension )

• Support preparation, review, and maintenance of validation lifecycle documents such as Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Reports under the guidance of senior CSVC personnel.
• Assist in the execution and documentation of testing activities including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and User Acceptance Testing (UAT) for computerized systems.
• Support change control activities by assisting in impact assessments, documentation reviews, and implementation verification in accordance with established procedures.
• Participate in deviation, incident, and CAPA investigations related to computerized systems under the supervision of senior CSVC personnel.
• Assist in maintaining validation compliance status of computerized systems and ensure documentation remains current, complete, and audit ready.
• Support vendor documentation review including supplier assessments, software documentation, and qualification packages as required.
• Coordinate with cross-functional teams including QA, IT, Engineering, Manufacturing, and Business Users to support validation and compliance activities.
• Assist in data integrity assessments and support implementation of data integrity principles in computerized systems in accordance with regulatory requirements.
• Support audit and inspection readiness activities by organizing, retrieving, and presenting validation documentation when required.
• Maintain accurate records and metrics related to validation projects, periodic reviews, change controls, and system inventories.
• Develop knowledge of applicable regulatory requirements and industry standards including GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and company procedures.
• Participate in training programs and complete all assigned learning requirements to enhance knowledge of Computer System Validation and compliance processes.
• Support retirement or decommissioning activities in accordance with established procedures and records retention requirements.
• Identify opportunities for process improvement and contribute to continuous improvement initiatives within the CSVC function.
• Ensure timely completion of assigned tasks and deliverables while maintaining quality and compliance standards.