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.
