Achieves approval to market the client's products in South Africa and neighbouring countries and assures that marketed products comply with regulatory requirements relating to product changes, labelling and advertising material, complaint reporting and release for sale of imported products. Ensures third party contractors of acceptable quality assurance principles and good manufacturing practices and good distribution practices as determined by SAHPRA and Corporate requirements.

Internal Relationships:

• General Manager
• Finance Department
• Human Resources Department
• Product Managers
• Sales & Marketing Managers
• Sales Representatives
• All assistants to the above departments

External Relationships:

• South African Health Products Regulatory Authority
• Medical professionals and public with product-related and/or medical queries
• Corporate Regulatory Affairs
• Corporate Quality Assurance
• Production
• Corporate Pharmacovigilance
• Research and Development
• Relevant contract laboratories
• Key persons at Warehousing and Distribution facilities
• Key persons at local contact manufacturing sites

Duties & Responsibilities:

• Ensure adherence of the client as a manufacturing pharmacy to SAHPRA and GMP Guidelines.
• Take corrective measures for deficiencies identified in the Inspection Reports of the Pharmacy Council.
• Assist RAM in ensuring that manufacturers, quality control laboratories and warehouses and distributors of the client's products comply with cGxP (including cGLP, cGDP) and RSA legal requirements.
• Ensure issues relating to QA, GMP, GLP and GDP and applicable legislation are communicated to the RAM in a timely manner.
• Apply for registration of new products with the South African Health Products Regulatory Authority (SAHPRA) and to selective Health Authorities of the neighbouring countries, when required.
• Product life cycle management.

Requirements:

• Qualified Pharmacist, Registered with the South African Pharmacy Council.
• Minimum 2-3 years’ experience in Quality Assurance.
• Good knowledge of Quality Management System and GMP Guidelines/regulations.
• Ability to work under pressure, take initiative and work independently when required.
• Strong organisational abilities.
• Cross-functional teamwork.

Behavioural Competencies:

• Achievement - Displays persistence in order to improve performance.
• Initiative-Anticipation - Pro-actively plans for short-term opportunities or prevents future problems.
• Customer & Brand Focus - Takes personal responsibility for the customer by ensuring that customer’s needs are handled efficiently, and queries are attended to promptly.
• Impact & Influence - Explains by using logical and concrete arguments & shows tenacity when persuading.
• Courage & Integrity - Acts in the best interest of the Company and the Law. Confidently makes decisions even when others clearly disagree.
• Innovation - Is open to new ideas and demonstrates a willingness to change ideas or perceptions based on needs that arise from new information or a new situation.
• Organisational Sense - Understands the chain of command & line of authority and supports decisions made by management.
• Co-operation - Acts in order to encourage good team relations over & beyond personal affinities.

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com

Should you receive no feedback within 7 days, please accept your application as unsuccessful.