CSV Specialist Job in Bangalore at leucine

Leucine is hiring for the role of CSV Specialist!

Responsibilities of the Candidate:

• Develop and implement validation strategies that align with GAMP 5 principles and regulatory requirements.
• Lead risk assessment activities to identify and mitigate risks associated with software systems.
• Create and maintain comprehensive validation documentation, including validation plans, test protocols, and validation reports.
• Coordinate and oversee testing activities to ensure systems are accurately validated and function as intended.
• Collaborate with development, quality assurance, and product teams to integrate validation activities throughout the software development lifecycle.
• Prepare and provide CSV packages to customers, ensuring they contain all necessary documentation and evidence of validation.
• Stay abreast of regulatory changes and industry best practices related to software validation in the pharmaceutical sector.
• Provide training and support to internal teams on CSV principles and practices.
• Lead continuous improvement efforts to enhance the CSV process and ensure the highest level of quality and compliance.

Requirements: 

• Bachelor's degree in Engineering, Life Sciences, or a related field
• A minimum of 2 years of experience in a CSV Specialist role within a software company, with a strong emphasis on systems used in the pharmaceutical industry
• In-depth knowledge of GAMP 5 guidelines, regulatory requirements, and industry best practices related to software validation
• Experience in developing validation documentation and conducting risk assessments
• Strong analytical, problem-solving, and project management skills
• Excellent communication and collaboration abilities, with a track record of working effectively in cross-functional teams
• Familiarity with regulatory requirements from agencies such as the FDA and EMA
• Certification or formal training in GAMP 5 or related quality management systems
• Experience in the pharmaceutical industry or with SaaS products targeted at this sector