About us
ALGOTEQUE is an IT consultancy firm that helps startups, mid-sized and large corporations to create and deliver innovative technologies. Our team has a successful track record in designing, developing, implementing, and integrating software solutions (AI, ML, BI, Web, Automation) for Telecom, Energy, Bank, Insurance, Pharma, Automotive, Industry, e-commerce. We deliver our services both in fixed-price and time-and-materials models, helping our customers achieve their business and IT strategies.
Job description
We are looking for an experienced CSV/CSA Expert to join a pharmaceutical project and support the transition from traditional Computer System Validation (CSV) to Computer Software Assurance (CSA) practices.
Responsibilities:
- Lead and support the transition from traditional CSV approaches to modern CSA practices.
- Define and implement risk-based validation and testing strategies in line with regulatory requirements.
- Promote the adoption of CSA principles across Configuration, Integration, QA, and other delivery teams.
- Advise teams on applying risk-based approaches to validation activities, reducing unnecessary documentation and testing while maintaining compliance.
- Support the validation of cloud-based and SaaS platforms in GxP environments.
- Collaborate with QA and Test Automation teams to align risk assessments with automated testing strategies and coverage.
- Provide expertise on regulatory requirements and validation best practices.
- Support regulatory inspections and audits as a CSV/CSA Subject Matter Expert (SME).
- Influence stakeholders and drive changes in validation practices across the organisation.
Required qualifications
- Experience in Computer System Validation (CSV), with demonstrated experience leading or supporting the transition to Computer Software Assurance (CSA).
- Knowledge of GAMP 5 (2nd Edition), FDA CSA guidance, 21 CFR Part 11, and EU Annex 11.
- Experience developing and implementing risk-based validation and testing strategies in regulated environments.
- Experience validating cloud-based and SaaS platforms within GxP environments.
- Understanding of quality, compliance, and software testing processes.
- Experience working with QA and Test Automation teams to align risk-based assessments with automated test coverage.
- Experience supporting regulatory inspections and audits as a validation SME.
- Strong stakeholder management, communication, and influencing skills.
- Ability to drive organisational change and encourage teams to adopt new validation practices.
Nice to Have:
- Experience with Veeva Vault validation.
- Experience working in pharmaceutical or life sciences environments.
- Experience introducing CSA methodologies across complex IT delivery organisations.