
Quality Assurance Professional
3 days ago
The ideal candidate will possess a strong background in quality assurance, with expertise in process improvement and risk management. Key responsibilities include reviewing documents from R&D, AR&D, and other departments to ensure accuracy, completeness, and compliance with internal and regulatory standards.
Key Responsibilities:
- Review and assess proposed process changes to ensure alignment with quality and compliance requirements.
- Promote quality by design principles to ensure process robustness and compliance throughout all stages of product development.
- Ensure adherence to stage-gate processes and conduct internal audits to support external inspections.
- Maintain accurate and comprehensive documentation for laboratory and plant operations, including SOPs and procedural documents.
- Prepare expert in-house quality reports and contribute to Quality Overall Summaries (QOS) for regulatory submissions.
- Identify opportunities for process and tool improvements to enhance efficiency, compliance, and quality.
- Facilitate risk assessments and actively monitor the implementation and effectiveness of mitigation plans.
- Coach and train cross-functional teams on quality best practices, fostering a culture of quality and continuous improvement.
- Ensure consistent compliance with applicable regulatory standards, including GMP, GLP, and GCP.
- Where applicable, ensure the integrity, accuracy, and reliability of datasets through data profiling, cleaning, and validation activities.
Required Skills and Qualifications:
- Strong background in quality assurance and process improvement.
- Expertise in risk management and compliance.
- Excellent communication and interpersonal skills.
- Ability to analyze complex data and develop effective solutions.
- Proficiency in quality management systems and regulatory requirements.
Benefits:
- A competitive salary package.
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
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