Compliance Specialist, Pharmaqms

2 days ago

Kempton Park, South Africa DSV Full time

**DSV - Global transport and logistics**

Location: Kempton Park
Job Posting Title: Compliance Specialist, PharmaQMS
Time Type: Full Time

**Main Purpose of The Role**:
**Minimum Requirements**:
Minimum 3 years relevant experience in industry

**Qualification Required**:

- Matric (essential)
- Logistics or Supply Chain Qualification or ISO 9001:2015
- Quality Management System
- Pharmacy / Healthcare / Similar qualification

**Computer packages**
- Office 365 (Teams, OneNote, Forms)
- MS Word, Excel, PowerPoint, Outlook
- Proficient in Excel for data management and reporting

**Duties and Responsibilities**:

- Ensure compliance to QSHE, standard operating procedure as well as statutory guidance documents.
- Write, review, train, implement, sustain & audit procedures / processes / workflows or other, as and when required to ensure compliance with adopted PharmaQMS and related Management Systems.
- Active participation in audits whether internal, client, statutory or other.
- Active participation in non-conformance closure through appropriate implementation of corrective action to ensure robustness of adopted PharmaQMS and related Management Systems.
- Active participation in continual improvement.
- Proactive engagement within operational undertakings to ensure prompt escalation to relevant manager in the event of system failure and / or operational weaknesses or necessary enhancements.
- Support the Management team through the communication of current issues and continuous improvement opportunities identified at Branch level. Tasks include (but are not limited to):

- Report writing in respect of KPI’s.
- Daily / Weekly / Monthly inspections aimed at PharmaQMS and related Management System
- Active participation in supervisory tasks, including but not limited to:

- Departmental resource management.
- Management meeting attendance.
- Ensure full site compliance, inclusive of DSV Policies, Health and Safety Regulations, processes, work Instructions, maintenance schedules, audits (internal and external), licenses, accreditations and local authority requirements.
- Quality Management based on ISO 9001:2015 & PharmaQMS.
- Appointment and maintenance of all roles within QMS framework.
- Training: Ensure all parties are trained effectively by accredited parties and licenses are renewed in time to prevent lapse.
- Health product identification and compliant storage, with segregation by resultant UN Code and/or MSDS category.
- Problem Solving: Effective Root Cause Analysis, Trend Analysis, Problem Solving and implementation of Corrective and Preventative Measures.
- 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 Quality audits.
- Consumer / Retail product management.
- Specialized packaging for Consumer / Retail product.
- High value product requiring specialized processes and storage arrangements.
- Stress and Conflict: Effective techniques and/or skills to manage conflict, cope with stress and work under pressure to meet deadlines.
- Supervision: All supervisory functions required within job description (Planning, Organizing, Leading, Controlling, Monitoring) carried out independently, effectively and reliably.
- 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 transport contractors are on DSV preferred provider list, meet all SHE requirements (compliant licenses, accreditations, processes, staff, training and equipment), have suitable safety file and are audited at regular intervals to ensure SHE standards are met at all times.

**Added Advantage**:

- Ability to demonstrate a proactive approach and continuously develop & improve quality, and other related obligations; and
- An understanding of quality assurance and audit processes in relation to the pharmaceutical industry and associated quality management systems
- Pharma QMS Auditor, or similar.

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