Key Responsibilities
1. Quality Assurance and Compliance
* Develop and maintain quality assurance procedures aligned with customer requirements and industry regulations (e.g., GMP, CE, UL).
* Oversee testing and validation efforts, including process and equipment validation (e.g., cleaning, metal finishing).
* Prepare for and support internal, customer, and regulatory audits; follow through on observations to ensure resolution and compliance.
* Provide QA oversight on New Product and New Process Introductions in collaboration with engineering and sales teams.
2. CAPA and Risk Management
* Lead investigations of non-conformances to identify root causes and implement corrective/preventive actions.
* Track and analyse quality trends to anticipate issues and drive improvements.
* Partner with technical and operational teams to embed preventative quality measures in processes.
3. Continuous Improvement
* Apply Lean and Six Sigma tools to enhance product quality and process efficiency.
* Execute quality improvement projects and contribute to problem-solving workshops.
* Support internal training and awareness initiatives on quality principles and best practices.
4. Supplier Quality Management
* Support supplier qualification and auditing processes to ensure compliance with specifications and traceability requirements.
* Work with procurement and suppliers to address quality issues and ensure continuous improvement in the supply chain.
5. Documentation and Reporting
* Maintain accurate, compliant records of QA activities, validations, audits, and CAPAs.
* Report on key quality metrics and continuous improvement initiatives to senior management.
Qualifications and Experience
* Bachelor’s degree in Engineering, Science, Quality, or related discipline.
* 5+ years' experience in a quality management or assurance role, ideally in pharmaceutical equipment or regulated manufacturing.
* Deep knowledge of GMP, ISO 9001:2015, ISO 14001:2015, and GDP standards.
* Demonstrated success managing quality systems, CAPAs, audits, and compliance independently.
* Strong analytical and project management skills.
* Proficient in Microsoft Office (especially Excel); experience with quality management software is a plus.
* Comfortable working cross-functionally and interacting with external auditors and customers.
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