Job Summary:
* We are seeking a skilled Quality Assurance Specialist to join our team.
* The ideal candidate will have experience in ensuring equipment, computerized systems, facilities, and utilities are qualified and maintained in compliance with regulatory, quality standards.
* This role provides quality oversight, technical support, and continuous improvement input to sustain the site's validated state.
Responsibilities:
* Review qualification and requalification protocols for equipment, systems, facilities, and plant utilities.
* Support execution of qualification activities, including area and drawing walkdowns and vendor interactions.
* Review related documents such as User Requirement Specifications, SOPs, drawings, and support files.
* Provide QA oversight and subject matter expertise on qualification, validation, and computerized system validation (CSV) activities.
* Lead investigations into qualification-related deficiencies and drive corrective and preventive actions.
* Generate, review, and maintain Validation Master Plans, policies, and SOPs.
* Approve calibration, preventive maintenance (PM) activities, and associated work orders.
* Track and manage annual validation schedules, periodic requalifications, and associated risk assessments or studies.
* Ensure ongoing audit readiness.
* Promote continuous improvement initiatives within validation and contribute to performance KPI reporting.
* Assist with training of QA and validation personnel and maintain validation documentation and archive systems.