1. PURPOSE OF POSITION

The position, reporting to the GMP (Quality Assurance Manager, is to foster and develop a culture of quality within the Supply Division, by monitoring and ensuring compliance with the Company Global Quality Systems, Good Manufacturing Practices and local Regulatory requirements and to ensure that all the Suppliers and it’s co-packers adheres to the required quality and GMP standards. Furthermore, to assess all Healthcare and Personal care products against registered requirements and authorise release for sale.

2. PRINCIPAL ACCOUNTABILITIES

? Maintains and improves Quality Standards of the business, by co-coordinating and conducting audits – internally, of all departments within the Supply Division and, externally, of suppliers and co-packers thereby ensuring compliance to Company Global Quality, GMP and Regulatory requirements.

? Evaluates and reports on audits, advises and recommends amendments / changes / adjustments / to systems and procedures to ensure corrective and preventive actions are implemented.

? Identifies and resolves quality problems, both internally and from outside suppliers (vendors of materials and co-packers).

? Contributes actively to the quality improvement of existing products through key Quality KPI objectives.

? Performs final product release of all personal care, cosmetics and healthcare products by reviewing batch documentation for compliance with regulatory requirements.

? Supports and assists with external audits (Suppliers, ISO 9001:2000, and SABS etc.)
? Co-ordinates and compiles documentation for healthcare products - Local Batch Packaging and Manufacturing docs in compliance with TDS; and Imported Packaging Checks and Analytical Test specifications for pharmaceutical products in compliance with registered dossiers.

? Approves artwork for healthcare and personal care products for compliance to quality requirements.

? Investigates the technical aspects of consumer complaints pertaining to all healthcare products by following up with co-packers and company Global sites and providing complaints investigative reports thereon.

? Advises Quality Assurance Manager and Supply Director of any significant risks to the business e.g. potential for product recall.

? Performs Annual Product Quality Reviews on all Healthcare products in compliance with regulatory requirements.

? Provides support and expertise to Supply personnel through Training to ensure that GMP Systems are maintained, problems resolved and prevented from reoccurrence and that quality systems are continuously improved.

3. Key Relationships Internal and External Group(Shared/Conflict interests)

Interactions:
Internal: Quality Manager, Regulatory Affairs Manager, Plant Manager, NPD/EPD, Supply Packaging, Manufacturing (WIP) & Packaging, Demand Planning, (Logistics and Planning Manager, Engineering, Procurement Manager, Marketing, Sales, Regulatory, Commercial Compliance Quality Manager.

External: Regional Quality Manager, Area Quality Director, External Stakeholders (suppliers, co-packers,
DC and warehouses, embellishers)

4. MAJOR CHALLENGES AND PROBLEM SOLVING

? Maintaining and improving quality systems.
? Resolving on-line issues regarding quality to the point of stopping production operation and restraining stock
? Ensuring quality standards are complied with by suppliers (vendors) of materials and third party manufacturers (Co-Packers).
? Decision-making regarding product release (responsible pharmacist for final product release of all pharmaceutical /healthcare products).
? Identifying and highlighting any quality risks to the business.
? Manage, motivate and support subordinates in meeting personal and business objectives
? Follows-up on corrective and preventative actions by managing all audit findings to ensure closure.
? Support the company culture through demonstrating and living the vision and values.
? Constructively challenge proposed business initiatives if GMP risks are identified

5. DELEGATED FREEDOM TO ACT

• Enforce compliance with GMP practices, SOP’s and QM Policies ,Product standards
and Regulatory requirements.
• Critically evaluate key systems and processes, and eescalate critical quality issues that may be a risk to the Business to Supply Management.
• Authorised to release healthcare products and personal care products in accordance with regulatory requirements.
• Review daily QBIC complaints file for potential issues and follow through investigation of Healthcare products.
• Coach, support and train direct reports (subordinates) to achieve personal and business objectives.

5. CONSEQUENCE OF ERROR

• Product recall / production loss if incorrect or substandard material used.
• Customer complaints – substandard product released into market.
• Not meeting statutory, regulatory and internal quality standards.
6. MANAGEMENT CONTENT

Directs QM team comprising of GMP Auditor to meet the objectives of the Quality Department.

7. PLANNING

Short Term: (Weekly) Work objectives, audits, reporting
(Daily) – Pharma product release, quality issues within the plant, material, quality issues from Suppliers, product quality issues from co-packers.

Medium Term: (Monthly) Internal and external audits
KPI reporting internally

8. ORGANISING, MONITORING AND CONTROLLING

? Organising – Direct reports; Prioritise product and material releases; Specific QM projects
? Monitoring – Systems and Process compliance; Quality KPI’s
? Controlling – NC reports, Communicating, report preparation

9. EDUCATION, EXPERIENCE, KNOWLEDGE, AND SKILLS

EDUCATION

- BPharm Degree and registration as a Pharmacist with the Pharmacy Council
- Qualification in Quality Management Systems (ISO)
- Min 3 years in Quality Control / Quality Assurance in a Pharmaceutical or FMCG company.
- 2 – 3 years in a supervisory / managerial position.

EXPERIENCE/SKILLS

1. Primarily a detailed but broad knowledge of all aspects relating to the Quality Assurance of pharmaceutical products, and other FMCG products. The job holder is expected to understand and act on implications which may not be apparent to those without the expertise.
2. Must be up to date at all times regarding knowledge of GMP and Regulatory requirements (MCC guidelines on Current Good Manufacturing Practice).
3. Sound knowledge of packaging analysis / evaluation and in-process requirements / controls within all aspects of the business.
4. Production and packaging process and technology (pharmaceutical and chemical)
5. Process control and principles / statistical evaluation (SPC) / Validation
6. Computer literacy
7. Quality Auditing ( suppliers, co-packers, internal)
8. Quality Systems (ISO 9000 Series, SABS Std,e-mark),
9. Project Management
10. Good Communication and Interpersonal Skills
11. Strong analytical and evaluative ability
12. Pro-activity and task oriented.

PERSONAL CHARACTERISTICS
? Integrity
? Self motivated
? Confident
? Proactive
? Committed to continual improvement, personal development and achievement of objectives
? Alertness
? Leadership qualities
? Personal development
? Able to mentor and coach
? Lead by example
? Assertiveness
? Follow-through
? Organising