Computer System Validation (CSV) and Data Integrity Specialist
We are looking to strengthen the team at LEF (Laboratório de Estudos Farmacêuticos) with a Computer System Validation (CSV) and Data Integrity Specialist.
Who are we?
Part of the ANF Group, LEF is a CRO and CMO providing high-quality services in the pharmaceutical and medicinal sectors. Our team consists of proactive top professionals who enjoy challenges and are committed to creating value in healthcare and society.
What do we offer?
An opportunity to join our Quality Assurance team, focusing on ensuring compliance with strict regulatory requirements regarding the treatment and integrity of electronic and paper data.
Main responsibilities include:
- Perform risk assessments of new computerized systems and equipment, ensuring data integrity by applying ALCOA+ principles;
- Develop, review, and execute qualification and validation protocols (IQ, OQ, PQ) for critical systems and equipment;
- Ensure compliance with GMP – EU Annex 11, GAMP 5, and 21 CFR Part 11;
- Support internal and external audits focused on data integrity;
- Collaborate with multidisciplinary teams on continuous improvement projects and new systems.
What are we looking for?
- Educational background in Pharmaceutical Sciences, Engineering, or related fields;
- Proven experience in the pharmaceutical industry, preferably in System Validation or Data Integrity;
- Strong knowledge and practical application of GMP, GAMP 5, 21 CFR Part 11, and Annex 11;
- Understanding of ALCOA+ principles and their implementation throughout the data lifecycle;
- Ability to work independently and in teams;
- Good communication skills and attention to detail.
If you are curious, innovative, enjoy working in a changing environment, and are looking for a new challenge, submit your application
#J-18808-Ljbffr