Quality Validation Specialist

Job Description

Key Responsibilities Include:

• QA lead for qualification of process equipment, utilities, computer systems, and lab equipment.
• Review and approve protocols pre-execution
• Review and approve executed protocols, summary reports, and collected evidence
• Assess qualification effort in relation to the final reports and conclusions made
• Perform periodic review of systems, equipment, utilities, and storage areas as part of our periodic requalification evaluation program.
• Monitor requalification due dates through use of a tracking spreadsheet
• Assess procedures, change controls, deviations, maintenance, calibrations, and service agreements in relation to maintaining the qualifies state of systems, equipment, or utilities.
• Author reports documenting assessments
• Review and assess temperature mapping studies for lab, stability, and material storage areas.
• Review and assist in shipping validation for late phase/commercial products.
• QA lead for process and cleaning validation
• Review and approve protocols pre-execution
• Review and approve executed protocols, summary reports, and collected evidence
• Assess validation documentation in relation to actions performed and conclusions made
• Initiate changes toward continuous improvement of site policies and procedures focusing on qualification and validation activities.
• Review and assess relevant change controls and deviations for impacts to qualified state.
• Develop effective CAPAs for investigations related to qualification/validation.
• Represent QA for qualification and validation related cross functional project teams.
• Assist QA in regulatory inspections and the site internal audit program.

Education and Experience Requirements:

Bachelors degree with 6 plus years of experience associated with validation, manufacturing, or facilities environments

• Prior experience in QMS systems such as deviations, CAPAs, change controls
• Prior experience authoring reports and procedures
• Prior experience in audits and inspections

• Excellent communication skills
• Strong attention to details

Additional beneficial experiences include:

• Knowledge of GAMP 5 and 21CFR Part 11 for computer systems
• Knowledge of ICH Q9, Quality Risk Management
• Knowledge of EMA, MHRA, and Health Canada regulations
• Knowledge of lifecycle approach to cleaning and process validation