Job Description
QA Systems & Validation Specialist
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The QA Systems Validation Specialist will be responsible for assessing changes to ensure GMP compliance in accordance with site change control procedures. This includes reviewing master and completed qualification and validation protocols, summary reports, and associated data to ensure conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
Key Responsibilities:
* Assessment of changes for GMP compliance in accordance with site change control procedure
* Review of master and completed qualification and validation protocols, summary reports, and associated data
* Qualification of premises, equipment, and utilities
* Computer system qualification (CSV)
* Laboratory equipment validation
* Provide expertise in the area of validation ensuring compliance with current industry regulations, guidelines, and trends
* Participation in cross-functional project teams as the quality assurance validation representative
* Review and approval of GMP design aspects of major capital projects
* Communication with all departments on site to ensure timely approval of change controls
* Implementation and execution of quality systems in compliance with ICH Q7, Eudralex, 21 CFR, and site Quality standards
Requirements:
* Min of BSc/BEng in Chemistry, Engineering, or a science-related discipline
* At least 3 years pharmaceutical experience, ideally in a QA role
* Experience in change control/documentation management, good manufacturing practices, and knowledge of relevant regulatory requirements for Data Integrity
* Strong interpersonal, communication, and presentation skills