Quality Manager

Key Accountabilities

Product Quality Control Maintain safe working conditions and practices within the area of responsibility. Perform work duties in accordance with Quality System Manual procedures and Omya procedures. Ensure all activities are conducted within the applicable guidelines of cGMP’s, FDA regulations and ISO 9001:2008 and FSSC 22000:2005 standards as they apply to the production of Food Grade and USP products. Conduct “mock recalls” to identify, quantify and isolate affected finished products. Supervise and/or perform the required quality testing on returned samples, retained samples, lot number samples, ore samples, in-process samples and compare test results and promptly inform Plant Manager in the case of irregularities. Track and explain test results to appropriate individuals. Work with regional laboratory and other contract laboratories if requested analysis cannot be done on site. Prepare test reports, distribute reports to requestor and file reports appropriately. Prepare samples for outside laboratory analysis as needed. Maintain storage of retained samples taken from outgoing shipments, lot number samples and customer samples. Responsible for generation of certificates of analysis/compliance and timely transmittal of certificates to shipping office and customers as well as orderly filing. Responsible for administering cGMP and other Food and Pharma related regulatory requirement programs and audits along with their implementation in the production process. Participate in the development of quality control procedures required for the quality systems manual; Review procedures periodically and recommend revisions if warranted. Responsible for evaluating and qualifying manufacturing process and consumables changes that may affect quality and availability of finished products, to include monitoring the USP monograph for changes related to calcium. Responsible for creating, administering, completing and filing validation plans for new or existing products at the required intervals per the governing regulation or procedures. Inspect, maintain and schedule service, repair and calibration of all laboratory equipment used for quality control, reporting damaged or defective equipment to Plant Manager. Research availability of new lab equipment and recommend purchases to management. Maintain stock of supplies in both laboratories. Maintain an adequate amount of product for sample orders, and appropriate certificate of analysis, and ensure that all products used for sample orders are within specifications. Responsible for periodic training of employees and selective contractors on cGMP practices and their implementation in the manufacturing and the quality control process. Perform Laboratory Technician duties, as necessary. Perform other duties as assigned by Supervisor and Plant Manager. QSHE

Compliance

Commit to continuous improvement in occupational safety/health, environmental protection, and quality management. Be aware and accustomed with the significant quality, safety/health, and environmental (QSHE) aspects/impacts associated with the work, including relevant legal/other requirements and emergency preparedness and response.

Solid line(s) to

Head of Sustainability (Region)

Dotted line(s) to

Head of QSHE

Number of direct reports

1 or 2

Number of total reports

1 or 2

Number of dotted line(s) reports

n/a

Performance Measures

KPIs agreed in yearly MbO.

Other requirements

Excellent command of both oral and written local language and English are required.Good command of both oral and written additional language is beneficial.

Internal contacts

Sustainability teamsOperations teamsLaboratory Technicians

External contacts

Vendors, suppliers, distributorsExternal laboratories and related service providersPlants and quarries, supplier sites

Education

University (Bachelor’s Degree) in Chemistry or related degree program

Experience

Minimum 5 years of experience in food and/or pharmaceutical manufacturing, preferably within food mineral processing, or an equivalent combination of education, training and experience.

Knowledge and skills

Strong operating knowledge of all laboratory equipment and test procedures, as well as processing equipment and manufacturing process. Excellent operating, troubleshooting skills for laboratory instruments are required. Excellent communication skills to effectively educate and train other personnel in quality related topics.Good organizational skills.Good analytical skills.

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