Divisional Manager:quality Assurance

**KEY RESPONSIBILITIES**

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**Strategy and Development**
- Contribute to the creation and implementation of best practice capacity planning vision, strategy, policies, processes and procedures to aid and improve operational performance
- Contribute to new business initiatives and projects and review and communicate the impact on Quality Management Systems (QMS)
- Responsible for achieving budget and forecast

**Operational management of the QA Department**:

- Drives delivery of day-to-day Quality Assurance activities, ensuring adherence to plan and schedule.
- Provides advice and knowledge regarding interpreting Good Manufacturing Practice guidelines and regulations.
- Liaising with suppliers with regards to quality issues and complaints - Reviews and approves raw material and finished product specifications.
- Identify change, increase efficiency, influence decisions and deliver results while ensuring compliance.
- Provides oversight and works directly in daily operations and systems within the Quality Assurance program to assure completions of activities on time and in compliance to regulatory guidelines.
- Release compliant products to market
- Monitors non-conformances or anomalies to the guidelines and GMP principles and provides timely input to ensure proper completion.
- Responsible for adherence to an audit program.
- Assesses and reviews the impact of excursions and deviations throughout the manufacturing and packing process.
- Maintains internal and external relationships.
- Assist with training in line with departmental training program when required.
- Management of departmental budgets in line with organizations financial objective
- Assists Supply chain as and when required

**Good Manufacturing practice (GMP, GLP, GWP)**
- Maintaining and coordinating all GMP principles
- Conduct risk assessments on a regular basis
- Monitor and approve temperature excursions during product transportation
- Provide Regulatory support relating to compliance and all GMP activities that might impact the dossier or SAHPRA/PIC/s.

**Documentation & Systems Management**

**Documentation**
- Managing the accuracy and completion of all databased entries, registers and forms
- Manages the implementation of new products in line with QA requirements
- Responsible for managing deviations, risk assessments and other related documents
- Writing and distributing of audit reports
- Compiling and presenting management review reports to the EXCO

**Systems**
- Drive operational efficiency by ensuring fit for purpose QMS
- Ensure ongoing compliance with the Quality Management System ISO standards
- Monitor overall process mapping for quality improvement purposes.

**Personnel Management**
- Setting up goals and objectives in alignment with Scientific Affairs departmental strategies
- Conducting Performance management and appraisals
- Manage conflicts when necessary
- Mentoring and coaching and developing of direct reports

PRE-REQUISITES
- B. Pharm registered with the SA Pharmacy Council
- 8- 10 years’ work experience in a quality assurance position within a pharmaceutical environment
- 5 years Management or supervisory experience strongly preferred