CSV Specialist
Bengaluru
Sales /
Full-time /
On-site
Why Leucine?
Leucine is a Series A funded B2B SaaS platform for the life sciences industry with over $10 million in funding from investors including Techstars, Axilor Ventures, and SAP Labs. Our mission is to make global drug manufacturing compliant and efficient. Within a short period, we have signed up Fortune 500 companies as customers and raised funds from marquee VC investors Some of the biggest pharma companies such as Cipla, Zydus, Dr. Reddy’s, Amneal and others around the world use Leucine's platform to ensure that the drugs they manufacture are safe & efficacious for patients.
Position Overview:
We are seeking a highly skilled and experienced Computer System Validation (CSV) Specialist to lead our CSV efforts. The successful candidate will be responsible for ensuring that every software release is validated in accordance with GAMP 5 guidelines and internal quality standards. This role involves developing validation strategies, conducting risk assessments, overseeing testing and documentation, and ensuring our CSV packages meet the rigorous demands of our customers in the pharmaceutical industry.
Responsibilities:
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.
Qualifications:
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.
Benefits:
Cultivate your best self within our purpose-driven work culture.
Encouragement for experimentation and freedom to innovate.
Competitive compensation aligned with industry standards.
Abundant opportunities for growth in a dynamic setting.
Weekday lunches provided by the company for added convenience.
Gain access to robust health insurance coverage for peace of mind.
Application Process:
Apply on Leucine's LinkedIn page or Lever, upload resume, and follow for updates.
