What is a QA Validation Specialist?
A QA Validation Specialist is a professional responsible for ensuring that finished products meet company standards by inspecting, assessing, and testing new product releases, integrations, and implementations. The QA Validation Specialists primary focus is on enhancing and maintaining the quality oversight and compliance systems for validation activities within a company. QA Validation Specialists are involved in supporting and coordinating day-to-day activities related to software validation, routine POMs (Process Order Master) QA support, and equipment calibration programs. They play a critical role in ensuring compliance with regulatory requirements and maintaining the quality of products and processes.
Duties of a QA Validation Specialist:
Routine POMs recipe validation and QA support: The specialist supports routine POMs recipe validation activities and provides QA support to ensure compliance and quality standards are met.
Development of validation protocols: They author, review, and issue Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for software, equipment, and facilities. They also report on the executed protocols as required.
Cleaning validation: QA Validation Specialists develop cleaning validation protocols and reports to ensure compliance with regulatory requirements after cleaning activities. They ensure that cleaning processes effectively remove contaminants and maintain the required cleanliness standards.
Management of Validation Master Plan: They assist in managing the site's Validation Master Plan and ensure its timely execution. The plan outlines the validation activities and strategies for maintaining compliance with regulatory standards.
Collaboration with other departments: QA Validation Specialists act as subject matter experts (SMEs) and collaborate with other departments such as Engineering, Pharmaceutical Technology, Equipment Maintenance, Manufacturing, Facilities, and QA Process Support. They provide quality oversight, regulatory advice, and support for projects within these departments.
Vendor management: In some cases, the specialist serves as a site contact for vendors and participates in off-site meetings, such as Factory Acceptance Testing (F.A.T), to ensure that vendor activities align with quality and regulatory requirements.
Laboratory equipment qualification: They provide QA support for the qualification of laboratory equipment by reviewing and approving protocols and reports.
Equipment calibration program: QA Validation Specialists maintain the site's equipment calibration program, ensuring that equipment performance is continually demonstrated. They track and report the performance of the on-site calibration program, ensuring that equipment is properly calibrated.
Feasibility studies and User Requirement Specifications (URS): They contribute to the execution of feasibility studies and review and contribute to the development of User Requirement Specifications, which outline the functional and performance requirements of systems or equipment.
Vendor documentation review: The specialist reviews and approves all vendor-supplied documentation to ensure it meets quality and regulatory requirements.
Risk assessments: They generate or contribute to risk assessments as required, identifying potential risks and developing mitigation strategies.
Authoring compliant documents: QA Validation Specialists author documents that ensure compliance with cGMP, such as Standard Operating Procedures (SOPs), investigations, Corrective and Preventive Actions (CAPAs), reports, and forms.
Process improvement and innovation: They seek process innovation and continuously improve the QA Validation area by identifying opportunities for improvement and implementing best practices.
Quality management system (QMS) improvement: The specialist supports the continuous improvement of the Quality Management System (QMS) by developing and implementing improved quality reporting measures and ensuring that equipment and cleaning validation status information is supplied for Annual Product Quality Reviews.
Support during audits: QA Validation Specialists provide direct support during competent authority audits and assist in conducting internal self-inspections and external audits as appropriate.
Maintenance of validation document archive system: They assist in maintaining the site's validation document archive system, ensuring proper documentation storage and accessibility.
Timely task execution: The specialist performs assigned tasks in accordance with procedural requirements and scheduled timelines. They promptly notify supervisors and stakeholders if procedural requirements or timelines are not being met.
Training: They carry out ongoing training of new and existing personnel, ensuring they are equipped with the necessary knowledge and skills related to validation activities.
Additional duties: QA Validation Specialists may be assigned other related duties or projects as required.
Similar roles to a QA Validation Specialist:
Validation Engineer: Validation Engineers specialize in designing, implementing, and managing validation activities for equipment, systems, and processes. They ensure compliance with regulatory requirements and industry standards and support the qualification and validation of manufacturing equipment and facilities.
Quality Assurance Specialist: Quality Assurance Specialists focus on ensuring compliance with quality standards and regulatory requirements across various areas of a company. They develop and implement quality systems, conduct audits, and provide guidance on quality-related matters.
Compliance Specialist: Compliance Specialists ensure that companies adhere to relevant regulations, standards, and policies. They assess compliance, develop strategies to address gaps, and provide guidance to maintain regulatory compliance.
Quality Control Analyst: Quality Control Analysts perform testing and analysis of products, materials, or samples to ensure they meet quality standards. While QA Validation Specialists focus on validation activities, Quality Control Analysts cover broader quality testing and analysis functions.
Regulatory Affairs Specialist: Regulatory Affairs Specialists navigate regulatory requirements and ensure compliance with applicable regulations and guidelines. They prepare and submit regulatory documentation, communicate with regulatory agencies, and provide regulatory guidance to internal stakeholders.