Executive (IT - CSV Computer System Validation)

We are seeking a skilled IT CSV (Computer System Validation) Executive to join our pharmaceutical team in Vadodara. The ideal candidate will ensure compliance with regulatory standards, optimize IT systems, and support validation processes critical to our operations.

Key Responsibilities:

• Perform validation activities for IT systems, including documentation, testing, and implementation, in compliance with GxP and regulatory guidelines.
• Develop and execute validation plans, test cases, and protocols for IT systems.
• Conduct risk assessments and mitigate risks associated with IT systems and software applications.
• Ensure compliance with industry regulations such as 21 CFR Part 11, GAMP 5, and other relevant guidelines.
• Maintain comprehensive documentation of validation processes, including plans, test scripts, and deviation reports.
• Collaborate with cross-functional teams, including Quality Assurance, IT, and Operations, to implement and maintain validated systems.
• Provide training to staff on validated systems and ensure adherence to best practices.
• Troubleshoot and resolve technical issues related to IT systems and applications.

Qualifications:

• Bachelor's or Master's degree in Information Technology, Computer Science, or a related field.
• 2 to 6 years of relevant experience in Computer System Validation (CSV) within the pharmaceutical or biotechnology industry.
• Strong knowledge of validation processes, including IQ, OQ, PQ, and software testing methodologies.
• Familiarity with regulatory requirements like FDA guidelines and EU Annex 11.
• Proficiency in IT tools, including database management and ERP systems.
• Excellent analytical, problem-solving, and communication skills.