13 Aug
|
Ampssco Technologies
|
Hyderabad
13 Aug
Ampssco Technologies
Hyderabad
Company Description Ampssco Technologies is a trusted life sciences consulting company specializing in engineering, validation, compliance, and digital transformation solutions. The organization partners with pharmaceutical, biotechnology, medical device, and healthcare companies to help them meet regulatory requirements and quality standards. By combining technical expertise with industry best practices, Ampssco Technologies supports clients in improving operational efficiency and reliability. The company focuses on technology-driven services that enable organizations to accelerate operational excellence while maintaining robust compliance across regulated environments.
Role Description The Computer System Validation Executive role is a full-time, on-site position based in Bengaluru South. The role involves planning and executing computer system validation (CSV) activities in alignment with regulatory guidelines and company policies. Day-to-day responsibilities include preparing validation documentation such as user requirement specifications, risk assessments, validation plans,
test scripts, and reports for GxP-relevant systems. The Executive will collaborate with cross-functional teams in IT, quality assurance, and operations to ensure that systems are properly qualified, validated, and maintained in a controlled state. The role also includes participation in audits, support for deviation and change control processes, and continuous improvement of validation methodologies and templates.
Qualifications
Solid knowledge of computer system validation methodologies, lifecycle documentation, and GAMP 5 or similar industry guidelines.
Understanding of regulatory requirements and quality frameworks such as FDA 21 CFR Part 11, EU Annex 11, GxP, and data integrity principles.
Ability to develop and review validation deliverables, including URS, risk assessments, IQ/OQ/PQ protocols, test scripts, and validation reports.
Experience working with IT systems used in pharmaceut
📌 Computer System Validation Executive (Hyderabad)
🏢 Ampssco Technologies
📍 Hyderabad