Responsibilities Include
Quality Assurance and QMS management
- Assist the Site Quality Leader in managing the business's Quality Management System, ensuring the effective implementation and maintenance of the quality management system, e.g., ISO 9001, GMP, EFfCI, Halal, and Kosher.
- Responsible for external quality audits, such as global, specific customer, and other quality audits as required, and ensuring that all findings or requirements are effectively addressed.
- Responsible for internal audits in accordance with global QMS requirements, maintaining an adequate number of cross-functional internal auditors to support the auditing processes.
- Responsible for supplier quality support for existing products, including supplier audits and approvals, manufacturing process plan reviews, raw material qualifications, etc.
- Safeguard the integrity of the QMS during planned and implemented changes at the site.
Process monitoring and improvement
- Monitor and report on the performance of the site QMS, highlighting opportunities for improvement to site and regional QMS management.
- Schedule and conduct site Quality Management System (QMS) activities such as management reviews and internal audits to assess performance and identify areas for improvement.
- Benchmark current processes against industry standards or competitors to identify and adapt best practices to meet the organization's needs.
- Ensure Quality/Regulatory Assurance to guarantee full compliance with all applicable standards.
- Promote quality awareness through training and initiatives.
Documentation and compliance
- Update and manage Quality Manuals and Procedures to align with business needs
- Maintain and distribute Standard Operating Procedures (SOPs) while ensuring their relevance and accuracy.
- Document, communicate, and enforce company quality policies across teams, support the creation of quality manuals, and ensure alignment with organizational goals.
- Ensure the proper maintenance of documents, document management systems, and action tracking systems, while upholding data integrity within the tracking system for the site.
- Ensure compliance with standards such as ISO, ASTM, and other relevant certifications, while staying up to date on applicable industry regulations and standards.
Collaboration, training and guidance
- Align QMS activities with the company’s strategic plans and business objectives.
- Collaborate closely with Production, Supply Chain, and Sales teams to ensure customer satisfaction with product samples and product quality
- Monitor and communicate emerging trends in customer expectations related to adherence and compliance with industry-specific quality standards beyond ISO.
- Collaborate with the QMS Leader to evaluate the adoption of additional standards and respond to customer needs.
- Deliver targeted training on topics such as ISO auditing, root cause analysis and corrective actions, Gensuite ATS, and the compliance calendar. Identify additional training needs to support skill development and maintain compliance.
Qualifications
The following are required for the role
- Highly motivated individual with strong organizational skills and experience in driving process improvements.
- Excellent organizational and communication skills used for coordinating cross-functional activities.
- Strong knowledge of quality standards and auditing processes.
- Proven experience in QMS implementation and ISO 9001 as well as GMP compliance.
- Ability to teach, train, and motivate others at varying levels within the organization.
- Ability to develop and align site objectives with global quality goals.
- Excellent presentation, facilitation, and problem-solving skills.
- Bachelor’s degree in chemical engineering, Chemistry or Chemical Sciences.
- Experience 3-5 years of experience in Quality management system
- Familiarity with the organization's processes, products, and services.
- Proficient in the qualification system and audit
- Computer literacy, Proficient in Microsoft Office applications
- Good command of English communication.
- Presentation skills to all levels
- Safety & Quality mindset.
