Senior Quality Validation Officer

Remarkable people, trusted by clients to design and advance the world. 

Wood is currently recruiting for a Senior Quality Validation Officer to support our growing operations in Singapore. 

#LI-Onsite

The Role

You will be responsible for ensuring that manufacturing facilities, processes, analytical methods, and computer systems are validated in full compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements. This role plays a key part in maintaining product quality standards and supporting smart manufacturing initiatives, with a strong focus on computer system validation.

What we can offer

Meaningful and interesting projects delivered to leaders of industry across renewable and emerging energy sectors 

Commitment to Diversity and Inclusion; we are an organization actively committed to diversity and inclusion across our business with employee networks committed to giving all employees a voice

Competitive salary with regular salary reviews to ensure we are rewarding at the right level in line with the market

Commitment to continued professional development; development plans that are tailored to your individual needs and interests

Global connections; join experts around the world who are at the leading edge of our industry, shaping the standards of our profession

Validation Planning & Documentation

• Draft, compile, review, and update policies and procedures supporting validation activities
• Prepare and approve validation protocols and reports ensuring consistency with agreed criteria
• Maintain thorough documentation for investigations and validation deliverables

Compliance & Regulatory Alignment

• Ensure validation activities meet cGMP and regulatory requirements
• Conduct periodic validation reviews and recommend re-validation as needed
• Approve Continued Process Verification (CPV) documents and ensure readiness for audits

Change Control & Risk Assessment

• Assess, review, and approve changes impacting product quality or validation status
• Implement robust change control processes aligned with quality systems
• Provide recommendations for follow-up actions from audits and investigations

Project Coordination & Leadership

• Act as Validation Coordinator for projects with product quality impact
• Chair Validation Working Party meetings and lead validation phases to meet project timelines
• Collaborate with cross-functional teams to ensure validation milestones are achieved

Investigations & Continuous Improvement

• Participate in investigations of failures, assess root causes, and evaluate corrective actions
• Drive improvements in validation processes and digital integration for smart manufacturing
• Support initiatives that enhance compliance and operational efficiency

Key Performance Indicators (KPIs):

• Accuracy and timeliness of validation documentation and reviews
• Alignment of validation activities with latest regulatory requirements
• Number of audit findings related to validation and change control
• Timely completion of validation milestones and project deliverables
• Thoroughness of investigations and documentation records
• Performance feedback from project managers and stakeholders
• Adherence to validation and project plan schedules

Decision-Making Scope:

Recommendations:

• Validation approach for new or modified systems
• Follow-up actions for audits and investigations
• Re-validation requirements based on periodic reviews

Decisions:

• Approval of deliverables for each qualification phase before proceeding to the next
• Approval of change control requests impacting validation status
• Jointly decide with NPI & Validation Manager on validation project outcomes

Professional:

• Bachelor's degree in Science or Engineering discipline.
• Minimum 5 years of relevant experience in pharmaceutical or regulated industries.

Technical:

• Extensive knowledge of GMP and computer system validation.
• Strong understanding of quality systems, manufacturing processes, and regulatory requirements.

Business:

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving capabilities.