1.0 - 4.0 years

1 - 3 Lacs

Ahmedabad, Bengaluru, Vadodara

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Role & responsibilities: Developing Validation Documentation and support for computerized systems used in GLP, GMP and GCP environments. (Manufacturing and Laboratory Systems) Developing Validation Documents and Execution of Validation Protocols. Validation Documentation will encompass validation plans, specifications, test protocols and standard operation procedures. Systems include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure. Preferred candidate profile Candidates must have experience/exposure to Computerized System Validation (CSV) especially PLC Validation 21 CFR Part 11, EU Annex 11 and GAMP 5. Good communication and technical writing skills are a must. Candidate should be ready to travel within Gujarat.

Posted 2 weeks 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 4 weeks ago

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