Pl and Sr Validation Analyst
Syntegon Telstar Brasil, a multinational consulting services company, is looking for Pleno and Senior Analysts to work with Equipment Qualification and Systems Validation activities within Greater São Paulo.
Develop documentation for equipment/utilities qualification and systems validation: Validation Plan, User Requirements (URS), Risk Analysis, Design Qualification (DQ), Installation (IQ), Operation (OQ), and Performance (PQ), as well as the Traceability Matrix. Execute qualifications and/or validations. Issue and/or review qualification and/or validation reports, periodic reviews, and computerized systems. Apply Good Manufacturing Practices (GMP) for medicines in pharmaceutical production units for oral solids, liquids, semi-solids, and injectables, as well as Good Laboratory Practices (GLP) standards. Participate in the evaluation of results and deviations found during protocol execution, analyzing them critically with the objective of concluding the qualification. Prepare and review operational procedures related to qualification and validation activities.
· Completed degree in Pharmacy, Chemistry, Information Technology, or Engineering. · Knowledge of Office package; · Previous experience with Equipment Qualification, Utilities and/or Computerized Systems Validation in the pharmaceutical industry or equivalent. · Intermediate English.
Work location: Greater SP - Jardim Arpoador