Minimum Requirements


A Health Sciences degree or Quality management Degree
ISO 9001:2015/14001:2015/45001:2018 and ISO 13485:2016
Advanced computer literacy level in MS Word, Excel, PowerPoint and Outlook
Experience in Quality Management Systems – implementation and maintenance
Knowledge of SAHPRA and SAPC guidelines


Job Related Requirements


Minimum 5-10 years relevant working experience in the Quality Assurance environment, preferable pharmaceutical warehousing, with experience in all job-related requirements and QSHE Management, including ISO 9001:2015/14001:2015/45001:2018 and ISO 13485:2016.


Requirements listed below:


Appointment and maintenance of all roles within SHERQ framework.
Management: All managerial functions required within job description (Planning, Organizing, Leading, Controlling, Monitoring) carried out independently, effectively and reliably.
Compliance: Must ensure full site compliance, including the following:
DSV Policies, Health and Safety Regulations, Processes, Work Instructions, Maintenance Schedules, Audits (internal and external), licenses, accreditations
Training: Ensure all parties are trained effectively by accredited parties and licenses are renewed in time to prevent lapse.
Compliant product storage aligned with MSDS category.
High value product requiring specialized processes and storage arrangements.
Problem Solving: Effective Root Cause Analysis, Trend Analysis, Problem Solving and implementation of Corrective and Preventative Measures.
Deviation/Incident Reporting: On time, professional, accurate and thorough incident reporting training, support and execution for internal and external clients.
Auditing: Preparation, execution and reporting of various site SHERQ audits.
Communication: Communicate effectively (written and verbal) to manage and meet both internal and external customer expectations.
Commercial: Ensure operations always compliant within framework of client contracts and SLA’s, supplier agreements and local authority legal requirements.
Contractor Management: Ensure all contactors are on DSV preferred provider list, meet all HSE requirements (compliant licenses, accreditations, processes, staff, training and equipment), have suitable safety file and are audited daily while on site to ensure HSE standards are met at all times.


Added Advantages for the role


Ability to demonstrate a proactive approach and continuously develop & Improvement quality, and other related obligations; and Knowledge of ISO 9001 and ISO 13485 standards Knowledge of GDP and GPP standards


Main purpose of the role


The successful incumbent will be responsible for the implementation, monitoring and maintenance of the applicable Quality Management Systems
To ensure effective quality assurance (QA) via the application of Quality Control (QC) processes, in order for DSV Solutions to comply with Good Distribution Practice, Client QA requirements, legal and ISO 9001 and ISO 13485 requirements and all regulatory requirements as laid down by the SAHPRA and SAPC.
Risk and incident management processes alignment and implementation


Duties and Responsibilities


Ensure QA requirements are met relating to the QC system and to the flow processes
Implement and maintain effective QC programs for procedures, processes, instruments and equipment used in the handling and storage off pharmaceutical products
Co-ordinate the client audits of DSV Solutions, as well as DSV Solutions feedback and follow-up thereof
Perform all third-party audits
Co-ordinate and manage all IISO audits
Liaise with relevant parties regarding QA policies and procedures
Ensure relevant QA//QC standards are applied in all DSV Solutions DC’’s.
Assist with general functions.
Understand and apply management dimensions.
Ensure application off management ability.
Demonstrate good Human Relations.
Identify problems and opportunities.
Ensure regulatory requirements are adhered to.
Exhibit accountability and positive attitude to achievement.
Compliance specialists in the Solutions branches
Daily / Weekly / Monthly inspections aimed at QSHE; and Risk Management: