The companys solutions are trusted by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001.
Who were looking for
We are looking for a skilled and motivated QA Lead and CSV engineer to join our Quality and Compliance team. This hybrid role combines expertise with Healthcare Quality Assurance (QA) support and Computerized Systems Validation (CSV) , and plays a critical part in ensuring that our software and internal systems meet applicable regulatory and industry standards and within GxP environments.
QA Lead
Act as a liaison between IT and QA functions to ensure proper system implementation and ongoing compliance.
Support internal and customer-facing QA processes, including audits, CAPA, change control, and documentation.
Manage periodic reviews and revalidation processes as needed.
Maintain compliance with relevant GxP guidelines and pharmaceutical regulatory requirements.
Contribute to the development, improvement, and enforcement of SOPs and quality policies.
Responsible for quality validation product per each release
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.
3+ years of experience in QA within a GxP environment, preferably in life sciences or pharmaceutical industry.
Experience with Computerized Systems Validation
Solid understanding of GxP , ISO 9001 ,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.
Bachelors 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.
