Lead Quality Assurance Engineer(CSV)

Found in: Whatjobs IN C2 - 2 weeks ago

hyderabad, India ValueLabs Full time
A Computer System Validation (CSV) Engineer is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals, medical devices, and biotechnology, meet the necessary quality, safety, and compliance requirements. The qualifications for a CSV Engineer typically include:
Responsibilities
To maintain consistent and documented compliance with all relevant Safety, Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements.
To identify and document computer systems which impact upon GxP and aid in the performance of the validation of identified systems
To quickly gain a detailed understanding of current vendor validation strategies and documentation packages for the validation of Grand Challenge projects currently ongoing.
Hold expertise in validation procedures and performance in line with GAMP5 guidance and how this is applied to highly complex automated systems.
Manage the validation full lifecycle of the software systems ensuring that they operate in compliance with GxP/ GAMP5 requirements.
Author and support others in the generation of the lifecycle CSV deliverables for each computer system, including validation plans, risk assessments, software testing, summary reports, configuration testing and change control.
Maintain appropriate validation documentation and files according to cGMP and CPI validation policies and procedures.
Qualifications
Looking 5+ experiance in CSV (computer system validation
A bachelor's degree in computer science, engineering, or a related field is generally required. Some positions may require a master's degree or higher in a relevant field.
Validation experience: Experience in computer system validation, including risk assessment, design, development, testing, and documentation, is necessary.
Problem-solving skills: The ability to analyze, troubleshoot, and resolve complex technical issues is essential for a CSV Engineer.
Communication and teamwork: Strong communication and collaboration skills are important for working with cross-functional teams and stakeholders.
Project management: Experience in managing multiple projects and meeting deadlines is beneficial.
"Candidate who can join immediately within 10 days: Please share your resume."

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