QA Validation Specialist

• Overseeing validation and qualification deliverables:
• Review and approve URSs.
• Review and approve qualification and validation plans.
• Review and approve validation documentation associated with equipment, facilities, and utilities (DQ, IQ, OQ, PQ).
• Review and approve the risk assessment related to equipment, facilities, and utilities.
• Review and approve the commissioning protocols and reports.
• Review and approve FAT/SAT documentation.
• Assure requirements traceability throughout the whole project validation file (from URS to PQ).
• Overseeing validation life cycle documentation:
• Review and approve equipment, facility, and utility life cycle documents.
• Ensure the correct application of the validation quality systems on the field and to define improvement plan.
• Understanding of cGMPs, GAMP, ICH Q7A, and validation practices (IQ/OQ/PQ) and their application in practice.
• Conducting periodic review of validated GxP equipment, facility, and utilities.
• Performing validation impact assessments prior to implementation of changes on equipment, facility, or utilities.
• Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable, and consistent operation of the system.
• Support the production & technical services teams in the implementation of the validation activities.
• Ensure the adequate management of validation deviations (be QA GMP Responsible) and potential CAPA (be Compliance Authority).
• Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.
• Contribute to continuous improvement and International standardization for topics related to equipment, utilities, and facilities.

What they ask

• Degree: Technical diploma / Bachelor of Science / Master of Science.
• Field of Study: Engineering, Biology / Biomedical science, Life Science, or other job-related discipline.
• Work Experience: Advanced - 5-10 years.
• Complies with Good Manufacturing Practices guidelines in all activities.
• Experienced with Quality Management and GxP Regulations.
• Knowledge of Validation Methodologies.
• Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP.
• Knowledge of the manufacturing processes.
• Excellent analytical skills with systematic approaches to problem solving.
• Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
• Sound industry knowledge, project proficiency, and autonomy expected.

Skills.

• Strong written and oral communication skills.
• Strong organizational and time management skills to carry out multiple assignments.