Job Summary
The Quality Assurance Specialist plays a critical role in ensuring compliance with regulatory and quality standards by qualifying equipment, systems, facilities, and utilities. This position provides quality oversight, technical support, and continuous improvement input to sustain the site's validated state.
About the Role
* Review and approve qualification and requalification protocols (IQ/OQ/PQ) for equipment, systems, facilities, and plant utilities.
* Support and oversee execution of qualification activities, including area and drawing walkdowns and vendor interactions (e.g., FAT).
* Review and approve 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, including data integrity compliance.
* Support laboratory equipment qualification and review associated protocols and reports.
* 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.
* Support internal and external audits (e.g., FDA, HPRA) and 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.
Responsibilities
* Conduct thorough reviews of qualification and requalification protocols to ensure compliance with regulatory and quality standards.
* Collaborate with cross-functional teams to execute qualification activities and ensure successful project outcomes.
* Develop and maintain comprehensive validation documentation, including User Requirement Specifications and SOPs.
* Provide expert guidance on qualification, validation, and CSV activities, ensuring data integrity and compliance.
* Identify and mitigate qualification-related risks through proactive investigation and corrective action.
Requirements
* Bachelor's degree in a relevant field, such as Engineering, Life Sciences, or Quality Assurance.
* Minimum 3 years of experience in Quality Assurance, Validation, or a related field.
* Excellent communication and interpersonal skills, with the ability to collaborate with cross-functional teams.
* Strong analytical and problem-solving skills, with the ability to identify and mitigate risks.
* Proficiency in Microsoft Office and other relevant software applications.