Job category: Other: FMCG, Retail, Wholesale and Supply Chain
Location: Gauteng
Contract: Permanent
EE position: Yes
IntroductionTo ensure Quality Management System (QMS) compliance through the development, management, and implementation of all quality policies, procedures, processes, programs, and practices, so as to ensure all operations comply with the appropriate standards and regulations and that continuous improvement is upheld.
Key ResponsibilitiesEnsure the Business unit is legally compliant in respect of the registration, packaging, warehousing, distribution, marketing, and selling of Healthcare products and services, ensuring compliance to GWP/GDP/GMP in all UPD distribution centers.Contribute to the organization's Business Strategy, provide strategic direction for the Quality Management function within the organization and be responsible for the human resources and financial management of the Division.Manage the implementation of batch recalls/withdrawals, self-inspection audits, vendor audits, temperature mapping, validation, and calibration of equipment required.Manage the point of contact with Distribution Principles, provide support and QA management to Distribution principals through ensuring favorable audits are achieved, formulating replies to audit reports, and ensuring that all observations are addressed.Ensure all relevant SOP's, annexures, training material, and tests are updated and implemented.Manage all quality and technical complaints, providing trend analysis and feedback on all deviations and change management that may impact distribution client products.Keep abreast with relevant legislation, guidelines, and the amendment and implementation thereof, ensuring compliance with all pharmaceutical regulations and alignment with all regulatory bodies.Responsible for the overall coordination and implementation of the quality management system and for ensuring all operational requirements are delivered.Coordinate the Business unit input into strategic regulatory submissions and liaise effectively with regulatory authorities and relevant stakeholders in order to obtain timely approvals.Oversee the review and assessment and formal reporting of business and financial risk exposures. Ensure that all key functional areas have a robust and effective business continuity plan (BCP).SkillsPeople ManagementHigh Level Relationship BuildingHigh level verbal and written communicationProblem Solving and Analytical ThinkingInfluencing and NegotiatingHigh level of integrityStrong interpersonal and communication skillsMust be able to multi-task; speed, efficiency, attention to detail and sense of urgency are importantExcellent organizational & project management skillsKnowledgeStrong Quality background and good pharmaceutical manufacturing/distribution knowledge with the ability to apply this across the organizationMedicines Control and Related Substances ActPharmaceutical Industry Laws and RegulationsKnowledge of Pharmaceutical Wholesaling and DistributionBusiness ProcessesHPCSA RegulationsProduct Registration ActGood Manufacturing/Pharmacy Practice GuidelinesDeciding and Initiating ActionRelating and NetworkingPersuading and InfluencingDelivering Results and Meeting Customer ExpectationsCreating and InnovatingFormulating Strategies and ConceptsLeading and SupervisingAnalysingEntrepreneurial and Commercial ThinkingWorking with PeopleApplying Expertise and TechnologyLearning and ResearchingEducation and QualificationsEssential: Registration with SAPCDesirable: Certified auditing qualifications advantageousExperienceEssential: Minimum of 8 years at a middle or senior management level with demonstrated experience in business/commercial aspects.Essential: Minimum of 5 years post-graduate experience in a Quality Management environment.
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