Dot Compliance empowers life sciences organizations to deliver life-saving products faster, safer, and more efficiently, by providing them with innovative AI-powered SaaS solutions to manage their quality and compliance needs.
We are looking for a skilled and motivated CSV and QA Lead to join our Quality and Compliance team. This hybrid role combines Computerized Systems Validation (CSV) expertise with Quality Assurance (QA) support, and plays a critical part in ensuring that our software and internal systems meet applicable regulatory and industry standards.
Computerized Systems Validation (CSV):
- Lead and execute validation activities for GxP-regulated system in accordance with FDA 21 CFR Part 11 and EU Annex 11.
- Create, review, and maintain validation documentation (VP,URS, FRS, VSR).
- Plan ,Review and approve test protocols (e.g. OQ,PQ)
- Collaborate with software engineering, product, and QA teams to ensure validation requirements are integrated into development and testing.
- Responsible for quality validation product per each release
- Manage periodic reviews and revalidation processes as needed.
- Support internal and customer-facing QA processes, including audits, CAPA, change control, and documentation.
- Maintain compliance with relevant GxP guidelines and pharmaceutical regulatory requirements.
- Contribute to the development, improvement, and enforcement of SOPs and quality policies.
- Act as a liaison between IT and QA functions to ensure proper system implementation and ongoing compliance.
- 3+ years of experience in CSV within a GxP environment, preferably in life sciences or pharmaceutical industry.
- Solid understanding of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidance.
- Experience with Quality Management Systems (QMS) and document control.
- Knowledge of IT/QA interfaces, including infrastructure qualification and data integrity requirements.
- Strong analytical and organizational skills, with keen attention to detail.
- Excellent verbal and written communication skills in English.
- Bachelorβs degree in Life Sciences, Engineering, Computer Science, or related field
Preferred Qualifications
- Experience in SaaS or software validation environment.
- Familiarity with Agile development processes.
- Exposure to customer audit support and regulatory inspections.