Document Review:
Review documents from R&D, AR&D, and other departments to ensure accuracy, completeness, and compliance with internal and regulatory standards.
Process Change Evaluation:
Assess and provide guidance on proposed process changes, ensuring they align with quality and compliance requirements.
Quality by Design:
Promote quality by design principles, ensuring process robustness and compliance throughout all stages of product development.
Compliance & Audits:
Ensure adherence to stage-gate processes, conduct internal audits, and support external inspections as required.
Documentation Management:
Maintain accurate and comprehensive documentation for laboratory and plant operations, including SOPs and procedural documents.
Quality Reporting:
Prepare expert in-house quality reports and contribute to Quality Overall Summaries (QOS) for regulatory submissions.
Process Improvement:
Identify opportunities for process and tool improvements to enhance efficiency, compliance, and quality.
Risk Assessment:
Facilitate risk assessments and actively monitor the implementation and effectiveness of mitigation plans.
Training & Development:
Coach and train cross-functional teams on quality best practices, fostering a culture of quality and continuous improvement.
Regulatory Compliance:
Ensure consistent compliance with applicable regulatory standards, including GMP, GLP, and GCP.
Data Quality Assurance:
Where applicable, ensure the integrity, accuracy, and reliability of datasets through data profiling, cleaning, and validation activities.

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