Job Description

RESPONSIBILITIES

Prepare and submit regulatory documents, including pre-market submissions, post-market surveillance reports, and product registrations to relevant regulatory authorities Review product labeling and promotional materials to ensure compliance with regulatory requirements Collaborate with cross-functional teams, including R&D, Quality Assurance, and Marketing, to provide regulatory guidance throughout the product lifecycle Monitor changes in regulations and assess their impact on the company's products and operations Support audits and inspections by regulatory bodies, ensuring readiness and compliance Develop, manage and review the quality management system in support of ISO 9001: 2015 accreditation Develop, implement, and review policies and procedures in support of an effective quality management system Maintain effective internal and external control systems that ensure compliance with standards, policies, and procedures Consult with various business units to ensure compliance to all processes and procedures Monitor and evaluate the application and effectiveness of the quality management system in all aspects of the organization. Identify and implement corrective measures and escalate areas of concern to line manager Ensure that all complaints are accurately logged and completed in full on the system Ensure Non-Conformance Reports (NCR) are available for analysis and action plans are in place to prevent or reduce re-occurrence Design and implement a SOP to manage returns and or recalls though full traceability including but not limited to batch number tracking Ensure full compliance to all national and international Quality Management Standards and relevant legislation Provide input to country specific requirements for the exporting of Finished Goods (FG's) Review defects/deviation rend reports and ensure action plans are in place Create an environment of compliance, continuous improvement, and sustainability in support of effective client relationships and improved value-added services. Ensure the relevant processes are in place to organise, coordinate and obtain the relevant certification including ISO certification Develop, implement, and conduct internal quality assurance audits Organise, prepare and co-ordinate external quality assurance audits Prepare and issue audit reports inclusive of findings and an action plan with the required corrective measures to be achieved within established timelines and or SLA's Ensure internal and external audit action plans are followed up, and manage all areas of non-compliance, according to established timelines and or SLA's Manage product information files and ensure that they are in line with national quality assurance standards and ISO requirements Ensure that all documentation (Certificate of Compliance (COA), Material Safety Data Sheet (MSDS), Certificate of Analysis (COA) is filed according to required standards, and in line with customer confidentiality requirements Compile, analyse and retain required reports including but not limited to audits reports, non-conformance reports for internal and external customers, complaints, statistical reports, and management review reports Develop, implement and monitor a customer complaints management system Ensure that customer complaints are recorded, processed, and closed within agreed timelines and according to required standards. Ensure that correct measures are implemented, and accurate records are maintained

REQUIREMENTS

Grade 12 or equivalent is required Qualification at NQF level 7 BCom, BSc, BA in business administration, quality management or related field is required Certification in quality management is a requirement * A valid code 8 driver's license