Location: Vadodara

Experience : 3+ Years

Responsibilities:

• Develop, execute, and document CSV protocols and reports for new and existing computer systems and software applications.
• Conduct risk assessments and gap analyses to identify potential quality issues and implement corrective actions.
• Develop and maintain quality documentation, including SOPs, validation plans, test cases, and reports.
• Participate in the selection, implementation, and qualification of new IT systems and software.
• Provide training and guidance to users on CSV and IT quality best practices.
• Collaborate with cross-functional teams (e.g., IT, engineering, manufacturing) to ensure compliance with regulatory requirements.
• Stay abreast of industry best practices and regulatory changes related to CSV and IT quality.
• Perform internal audits and support external audits related to CSV and IT quality.

Qualifications:

• Bachelor’s degree, or a related field.
• 3-4 years of experience in CSV and IT quality assurance within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices).
• Strong understanding of GxP regulations (e.g., 21 CFR Part 11, Annex 11) and industry best practices for CSV.
• Experience with software development lifecycle (SDLC) methodologies and quality management systems (QMS).
• Excellent written and verbal communication skills, with the ability to effectively communicate technical information to both technical and non-technical audiences.
• Strong analytical and problem-solving skills.

Ability to work independently and as part of a team.

Kindly share your updated resume

ruchita.parsekar@e-stonetech.com