Vacancy For Software Engineer/ Engineer-csv, Hetero, Hyd.

2 - 5 Years

Job Description

* Write, maintain, review and design specifications (URS/ FS/ DS), Protocols (IQ/ OQ/ PQ/ CSV), Validation Plans, Qualification Plans, System Level Impact Assessments, Component Level Impact Assessments, GxP Assessments, Traceability Matrices, Risk Management Plans, Validation Summary Reports, Quality Systems (Change Control, Non - Conformances, Re - qualification)

* Responsible for planning, managing, and executing the Computer System Validation oversight program of computerized systems, including reviewing and approving computerized system validation documentation and IT change controls for compliance with 21 CFR Part 11, EU Eudralex Vol 4 Annex 11 and GAMP 5 principals / life cycle concept.

* Facilitates and leads Validation process improvements and readiness initiatives related to electronic system development life cycle, validation processes, IT systems/ processes, data integrity control processes, and regulatory compliance processes.

* Issue Management and CAPA (Corrective Action and Preventative Action) documentation and execution.

* Experience in Agile Methodology

Salary: Not Disclosed by Recruiter

Industry:IT-Software / Software Services

Functional Area:IT Software - Application Programming, Maintenance

Role Category:Programming & Design

Role:Testing Engineer


Desired Candidate Profile

Please refer to the Job description above


UG:B.Tech/B.E. - Any Specialization, Computers, B.Sc - Any Specialization, Computers

PG:MCA - Computers, M.Tech - Computers, Any Specialization

Company Profile

Hetero Drugs Limited

M/s. Hetero Drugs Ltd., is one of the Largest Pharmaceutical Company in India.
View Contact Details+

Recruiter Name:Kesava Pani

Contact Company:Hetero Drugs Limited


Reference Id:SE - CSV


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