Assistant Manager | Others| SAP

Involved into Validation of Software Applications, Computer systems. Involved in GxP Analysis, Gap Assessment, ERES Assessment Involved in Software Development Life Cycle (SDLC), Software Testing Life Cycle (STLC) and Testing methodologies. Involved in Software Quality Assurance and Risk Management. Involved in review of GAMP Guidelines Ensuring that the entire project life cycle phases are compliant with Clients SDLC methodology Reporting Compliance status to Global leadership Understand and ensure applicability of Computer System Validations for the complex change management environment as operating in regulatory compliance framework. Knowledge of 21 CFR Part 11 of USFDA, EU Annexure 11 Experience in FDA regulated environment with good understanding of cGxP. Involved in assessments for GxP relevance and for 21 CFR Part 11 like ERES Coordinate Incident Management, along with the related corrective and preventative actions required to establish/maintain validated systems Evaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes Support and provide input into system administration and maintenance procedures to ensure adequate controls for maintaining the validated state Acts as a quality contact and primary Subject Matter Expert (SME) for Computer System Validation (CSV) and Quality Risk Management The key skills required are as follows: Should have completed at least two end to end computer validation projects Experience in regulations such as 21 CFR Part 11 and Annexure 11 Experience in GAMP 5 A background on Quality systems such as CMMi or ISO Proven track record in validation and qualification of complex computer systems Demonstrable knowledge of GxP environs such as cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11 and GAMP standards