Job category: Other: FMCG, Retail, Wholesale and Supply Chain
Location: Gauteng
Contract: Permanent
EE position: Yes
Introduction
To 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 Responsibilities
- Ensure 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).
Skills
- People Management
- High Level Relationship Building
- High level verbal and written communication
- Problem Solving and Analytical Thinking
- Influencing and Negotiating
- High level of integrity
- Strong interpersonal and communication skills
- Must be able to multi-task; speed, efficiency, attention to detail and sense of urgency are important
- Excellent organizational & project management skills
Knowledge
- Strong Quality background and good pharmaceutical manufacturing/distribution knowledge with the ability to apply this across the organization
- Medicines Control and Related Substances Act
- Pharmaceutical Industry Laws and Regulations
- Knowledge of Pharmaceutical Wholesaling and Distribution
- Business Processes
- HPCSA Regulations
- Product Registration Act
- Good Manufacturing/Pharmacy Practice Guidelines
- Deciding and Initiating Action
- Relating and Networking
- Persuading and Influencing
- Delivering Results and Meeting Customer Expectations
- Creating and Innovating
- Formulating Strategies and Concepts
- Leading and Supervising
- Analysing
- Entrepreneurial and Commercial Thinking
- Working with People
Applying Expertise and Technology
Education and Qualifications
- Essential: Registration with SAPC
- Desirable: Certified auditing qualifications advantageous
Experience
- Essential: 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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