About Us
Leucine offers modern software that empowers pharma companies to get a 360-degree real-time view of the FDA GMP compliance across their manufacturing network, CMOs, and Suppliers. Every day, hundreds of Quality teams around the world use Leucine's applications, platform, and, analytics to effortlessly ensure that the drugs they manufacture are safe, and, efficacious.
Leucine is growing rapidly on its mission 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.
Job Description:
As a Computer Systems Validation Consultant, you will play a critical role in our software application qualification process. You will be responsible for ensuring that our software applications meet the requirements of the FDA and EU regulations, and our internal quality standards.
Your key responsibilities will include:
- Developing and executing computer system validation protocols for software applications used in the pharmaceutical industry.
- Leading and participating in cross-functional teams to ensure validation activities are completed on time and to the highest standard.
- Reviewing and approving validation documentation to ensure compliance with regulatory requirements and internal quality standards.
- Providing guidance to project teams on CSV regulations and best practices.
- Identifying and resolving compliance issues during the validation process.
- Maintaining knowledge of current regulatory requirements, guidelines, and industry best practices
Requirements
Qualifications:
- Bachelor's degree in a relevant field, such as engineering or a life science-related field.
- At least 2 years of experience in CSV in the pharmaceutical industry.
- Knowledge of FDA regulations and guidance related to computer system validation, including 21 CFR Part 11 and Annex 11.
- Experience developing and executing validation protocols, test scripts, and validation reports.
- Excellent written and verbal communication skills.
- Strong problem-solving skills and attention to detail.
- Ability to work independently and as part of a team.
If you have a passion for ensuring the quality and compliance of software applications and want to work in an industry that has a real impact on people's lives, we would love to hear from you. Apply now to join our team as a Computer System Validation Consultant.
Benefits
- A purpose-built work culture that lets you achieve the best version of yourself
- Freedom to experiment and autonomy of ideas
- Market competitive compensation
- Ample opportunity to grow in a fast-paced environment
- Health Insurance.