Systems Validation
QIMA Life Sciences (ICF) is a fast-growing division of the QIMA Group, dedicated to providing comprehensive services for the life sciences industry – from R&D to market launch.
In Brazil, we operate through 5 entities – ICF, Apex Science, Labmass, Lychnoflora, and CP Quali – with 450 talented professionals providing services ranging from clinical trials to quality control. QIMA is more than a testing, inspection, certification, and compliance company. Our mission is to offer customers intelligent solutions to create products that consumers can trust. With a global reach spanning over 100 countries, QIMA serves the consumer products, food, and life sciences industries, supporting more than 30,000 brands, retailers, manufacturers, and food producers. The company combines local expertise with digital solutions to bring precision and visibility to quality, safety, and compliance data. What sets QIMA apart is its unique culture: 6,000 employees live and make decisions every day according to QIMA values. With customer passion, integrity, and a commitment to simplifying things, QIMA continues to revolutionize the testing, inspection, and certification industry.
Job Description: Mastery of validation methodologies and frameworks: GAMP 5, validation lifecycle (URS, FRS/DS, IQ, OQ, PQ). Knowledge of regulatory standards: 21 CFR Part 11, Annex 11 (EU GMP), applicable ANVISA RDC. Experience with risk management applied to validation (e.g., FMEA, risk matrix). Knowledge of change control and deviation management (deviations/CAPA). Familiarity with quality management and documentation tools. Professional Experience Experience in computerized systems validation (CSV) or process/equipment validation. Experience in regulated environments (pharmaceutical, medical devices, food, cosmetics) is a differentiator. Previous experience in regulatory audits and inspections (ANVISA, FDA, EMA) is desirable.
Academic Background Completed degree in Engineering (Production, Chemical, Electrical, Computing), Pharmacy, Biological Sciences, Computer Science, Information Systems, or related areas. Post-graduate degree in Quality, Validation, Regulatory, or Information Systems Management (desirable). Languages Intermediate/advanced English (reading of standards and technical documentation); Differentiators (optional) Quality certifications (Six Sigma, ISO Lead Auditor). Experience with ERP, LIMS, MES, or electronic QMS systems.
Behavioral Competencies Rigorous attention to detail and documentary organization. Good written and verbal communication, with the ability to report technical risks to non-technical audiences. Autonomy to manage multiple projects simultaneously. Collaborative posture to interact with IT, Quality, Operations areas, and suppliers. Analytical capacity for failure investigation and problem-solving. Remuneration Remuneration: to be agreed upon; Contract type: PJ.