Quality Assurance Validation Specialist
2 weeks ago
Position Title: Quality Assurance Validation Specialist
Role Overview:
As a Quality Assurance Validation Specialist, you will collaborate closely with a network of manufacturing, development, and quality partners, ensuring that the organization’s interests in quality and compliance are upheld. You will be responsible for updating management on the status of deliverables and identifying critical activities and risks.
Key Responsibilities:
• Partner with various stakeholders to ensure compliance activities are effectively maintained to support cGMP standards, including calibration, validation, and environmental monitoring.
• Review and endorse validation documents, plans, protocols, and reports to ensure adherence to compliance standards.
• Participate in onsite evaluations of contractors and equipment manufacturers to facilitate validation processes.
• Assist in the implementation of GMP software systems, acting as the subject matter expert for qualification, training, and ongoing system management.
• Ensure that computerized systems align with corporate standards and best practices, including involvement in the change control committee.
• Review and approve System Life Cycle Deliverables for computerized systems, ensuring compliance with corporate procedures and regulatory standards.
• Provide support to business stakeholders by verifying that systems meet established requirements in a compliant manner, including communicating updates and changes.
• Ensure comprehensive documentation is produced to support validation activities for GxP systems.
• Aid in tracking quality commitments and change control processes to ensure that manufacturing changes comply with regulatory requirements.
• Act as a reviewer and approver for quality-owned Standard Operating Procedures (SOPs) within the electronic documentation management system.
Essential Skills:
• Quality Assurance
• Validation Engineering
• Regulatory Compliance (FDA)
Work Environment:
This role is based in a collaborative environment with a small team within the Quality department, expected to experience significant growth.
About Actalent:
Actalent is a global leader in engineering and sciences services and talent solutions, dedicated to helping innovative companies advance their engineering and science initiatives through access to specialized experts.
Diversity, Equity & Inclusion:
Actalent is committed to fostering a diverse and inclusive workplace, ensuring equitable opportunities for all employees.
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