Manager, Quality, Solutions
- Kempton Park, Gauteng
- Permanent
- Full-time
Job Posting Title: Manager, Quality, Solutions
Time Type: Full timeMinimum RequirementsA Health Sciences degree or Quality management DegreeISO 9001:2015/14001:2015/45001:2018 and ISO 13485:2016Advanced computer literacy level in MS Word, Excel, PowerPoint and OutlookExperience in Quality Management Systems - implementation and maintenance
Knowledge of SAHPRA and SAPC guidelinesJob Related RequirementsMinimum 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.
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 implementationDuties and Responsibilities
- Ensure QA requiirementts are met relatiing 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-ordiinatte and manage all IISO audiitts
- Liaise with relevant parties regardiing QA policiies and procedures
- Ensure relevant QA//QC standards are applliied in all DSV Solutions DC''s.
- Assist with general functions.
- Understtand and appy management dimensions.
- Ensure application off managementt ability.
- Demonstrate good Human Relations.
- Identtiiffy 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: