Job Description

Headline Responsibilities: Ensure that the Quality Management system is in place and conforms with all relevant Quality standards which include ISO 22716 Ensure the organization is adequately prepared for all external and third party audits like SABS, good corporate practice Prepare the organization for ISO9001 certification and any other GMP standards it may choose to pursue Manage and keep updated the site Quality Manual and conduct training Assures consistent quality of production by developing and enforcing good (automated) manufacturing practice GMP and (GAMP) systems, validating processes, providing documentation, and managing staff. Accomplishes quality assurance human resource objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching, counselling, and disciplining employees and planning and reviewing compensation. Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; and implementing change. Manage and improve internal process which will include: Producing batch sheets Signing off specifications Verifying legality of artwork Verifying the quality of artworks and finished products Verifying the capability of newly introduced machines. Complete Internal Audits to a high standard and follow up by closing actions and audit reports. Respond to any customer complaints and ensure that appropriate Corrective and Preventive actions are established, and to be accountable for the success of these actions. making sure that manufacturing or production processes meet international and national standards Ensure that the site QC team are trained and equipped to carry out QC work to a high standard. Ensure SOPs are followed, and that training on SOPs is conducted and adherence to SOPs is monitored. To control deviation from Bills of Materials, product specifications and internal processes. Manage the site Document Control System and ensure that only released documents are available for use. Manage Change Control through the Quality Management System and ensure that changes are documented within the DCS and communicated accordingly to all relevant parties. Devise and review specifications for products or processes Working with purchasing staff to establish quality requirements from external suppliers Setting standards for quality as well as health and safety Looking at ways to reduce waste and increase efficiency Defining quality procedures in conjunction with operating staff Setting up and maintaining controls and documentation procedures Validates quality processes by establishing product specifications and quality attributes, measuring production, documenting evidence, determining operational and performance qualification, and writing and updating quality assurance procedures. Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits, and investigating customer complaints. Collaborates with other members of management to develop new product and engineering designs, and manufacturing and training methods. Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations. Oversee all product development procedures to identify deviations from quality standards Keep accurate documentation and perform statistical analysis Submit detailed reports to appropriate executives
Quality Assurance Qualifications / Skills: At least 5 years experience in establishing, implementing and has achieved GMP audit training Outstanding Internal auditing skills GMP Pharmaceutical, Science or Food technology or related qualification or similar experience Computer literate; MS Office (Excel, PowerPoint, Word) Report writing skills Investigative and analytical skills Management and Leadership skills Lab management experience Service Provider and Customer Relationship Management Time management and priority management Facilitation Problem solving Drivers licence and own transport Experience in quality management within a manufacturing company and Quality Management.

Skills Required