Job Title:  Assistant Manager | Others | Pune | 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