Senior Quality Validation Officer

Overview

Ensures validation of facilities, processes, methods, and systems per cGMP.

Key Responsibilities

• documentation
• change control
• regulatory compliance
• audit follow‑up
• protocol approval
• process verification

Tasks

-Maintain thorough documentation for investigations and validation deliverables -Timely completion of validation milestones and project deliverables -Implement robust change control processes aligned with quality systems -Collaborate with cross-functional teams to ensure validation milestones are achieved -Drive improvements in validation processes and digital integration for smart manufacturing -Conduct periodic validation reviews and recommend re-validation as needed -Assess, review, and approve changes impacting product quality or validation status -Alignment of validation activities with latest regulatory requirements -Follow-up actions for audits and investigations -Support initiatives that enhance compliance and operational efficiency -Draft, compile, review, and update policies and procedures supporting validation activities -Ensure validation activities meet cGMP and regulatory requirements -Act as Validation Coordinator for projects with product quality impact -Provide recommendations for follow-up actions from audits and investigations -Chair Validation Working Party meetings and lead validation phases to meet project timelines -Prepare and approve validation protocols and reports ensuring consistency with agreed criteria -Approval of change control requests impacting validation status -Participate in investigations of failures, assess root causes, and evaluate corrective actions -Jointly decide with NPI & Validation Manager on validation project outcomes -Approve Continued Process Verification (CPV) documents and ensure readiness for audits

Requirements

• bachelor's
• gmp
• validation
• quality systems
• 5+ years
• analytical

What You Bring

-Adherence to validation and project plan schedules -Excellent communication and interpersonal skills. -Bachelor’s degree in Science or Engineering discipline. -Strong understanding of quality systems, manufacturing processes, and regulatory requirements. -Approval of deliverables for each qualification phase before proceeding to the next -Extensive knowledge of GMP and computer system validation. -Thoroughness of investigations and documentation records -Minimum 5 years of relevant experience in pharmaceutical or regulated industries. -Accuracy and timeliness of validation documentation and reviews -Validation approach for new or modified systems -Strong analytical and problem-solving capabilities.

People Also Searched For

About Wood

-Wood is a global leader in consulting and engineering, primarily serving the energy and materials markets. -The company offers a wide array of services including project and construction management, operations and maintenance, and engineering design across various sectors such as oil and gas, chemicals, renewable energy, and infrastructure. -Wood operates in multiple countries including Australia, Canada, England, UAE, and the US, with a growing emphasis on sustainable energy and decarbonization technologies. -The company provides an integrated service model covering advisory, design, delivery, operational support, and repurposing services.

Sector Specialisms