6.0 - 8.0 years

0 Lacs

Pune, Maharashtra, India

On-site

Job Description: A day in the life of an Infoscion As part of the Infosys consulting team your primary role would be to actively aid the consulting team in different phases of the project including problem definition effort estimation diagnosis solution generation and design and deployment You will explore the alternatives to the recommended solutions based on research that includes literature surveys information available in public domains vendor evaluation information etc and build POCs You will create requirement specifications from the business needs define the to be processes and detailed functional designs based on requirements You will support configuring solution requirements on the products understand if any issues diagnose the root cause of such issues seek clarifications and then identify and shortlist solution alternatives You will also contribute to unit level and organizational initiatives with an objective of providing high quality value adding solutions to customers If you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you Key Responsibilities: Key components of the responsibilities are as mentioned below but not limited to 6 yrs of Professional experience and strong knowledge with real time experience in IT Quality Compliance Computer System Validation Software Testing System Implementation in the Life Sciences industry Leads the effort to manage and or maintains validation of the GxP computerized systems Create Validation Plan Validation Report and Reviews validation documents such as URS FS FRA DD IQ OQ PQ s TRM Assure compliance with GxP GMP GCP GLP privacy requirements Develops and maintains IT GxP compliance documentation Ensure GxP Computerized Systems are validated as per GAMP 5 requirements Stakeholder management and good executor with required communication Candidate must have fair conceptual understanding on below key areas o IT QMS o Validation Qualification o Risk management o Handling of defects Deviations o Investigations o CAPA Handling o Test Management Compliance Candidate must have understating on latest regulations i e 21CFR Part 11 EU annex 11 and Guidelines e g GAMP5 guide Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i e standalone enterprise etc Technical Requirements: Hands on experience on testing tools like HP ALM Kneat and SNOW Experience to MES QMS Trackwise Lab solutions i e LIMS Empower CDS Chromeleon Business Analytics Middle wares etc will be an advantage OT System Qualification Radio ligand Therapy or critical dosage forms will be a plus PAS DCS Qualification ISA95 High level of understanding OT Security will be a plus Standalone Systems Qualifications PAS DCS Integrated with Manufacturing Equipment qualification Preferred Skills: LS Domain->Computer System Validation (CSV)

Posted 6 days ago

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CSV Validation Engineer Cleanstep Pharma And Engineering Solutions

2.0 - 7.0 years

3 - 8 Lacs

Hyderabad, Pune, Mumbai (All Areas)

Work from Office

Roles and Responsibilities Conduct CSV activities such as risk assessment, gap analysis, and validation planning. Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11. Ensure compliance with EU Annexure 11 requirements for software validation. Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems. Develop test scripts and execute tests using V-model approach. Preparation, Execution, Compilation and approval of below documents (Not limited to) 1) User requirement specifications 2) Validation Plan 3) GxP Assessment 4) System Design Specification 5) Risk Assessment 6) Network (Infra) Qualification 7) Installation Qualification protocol 8) Operational Qualification 9) Performance Qualification 10) Traceability matrix 11) Validation summary report

Posted 1 month ago

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