Requirements
Bachelor's degree in Pharmacy, Science or a related field.4–7 years of relevant experience in QA Validation/Qualification within the pharmaceutical industry.Strong knowledge of GMP and validation principles.Hands-on experience in equipment, process, cleaning, utilities, and/or computerized system validation.Good knowledge of risk assessment and validation documentation.Strong analytical, problem-solving, communication, and organizational skills.Good command of English.
Description
Plan, review, and execute qualification and validation activities, including equipment, utilities, facilities, processes, cleaning, and computerized systems.Prepare and review validation protocols, reports, risk assessments, and related documentation.Ensure validation activities comply with cGMP, regulatory guidelines, and approved procedures.Review validation deviations, investigations, and CAPAs and ensure timely closure.Coordinate with Production, Engineering, QC, IT, and other functions to ensure effective execution of validation activities.Support regulatory and internal audits related to validation and qualification.Monitor validation status and ensure timely completion of the validation plan.Provide technical guidance to junior team members and support continuous improvement initiatives.