Quality Assurance Assistant Jobs

Introduction

We are seeking a Quality Assurance Assistant to join the United Pharma Marketing division at our Head Office. This role reports to the Regulatory Affairs Manager.

Job Description

Key Objectives

• Liaise with the Clicks in-house advertising agency (BTB), Marketing & Distribution Partners, and their Suppliers/Manufacturers to ensure timely and accurate preparation of all printed materials. This includes compiling and proofreading Product Information (PI), Patient Information Leaflets (PIL), and product packaging artwork, following standard operating procedures (SOPs) to meet legal, regulatory, and marketing code requirements, as outlined in relevant Technical Quality Agreements (TQAs).
• Deliver regulatory-compliant marketing, promotional, and educational materials on time through effective communication and proactive management of stakeholders, using logistics and resources efficiently.
• Work with multiple stakeholders to list products on all relevant internal and external IT systems by project deadlines.
• Create and manage project management tools (such as trackers) to ensure accurate and timely delivery on commercial expectations.
• Apply good document management practices to maintain regulatory and legal compliance, including traceability and version control.
• Keep all filing of advertising and marketing printed materials up to date.
• Stay informed about new pharmaceutical and regulatory trends, especially those related to advertising and marketing materials for healthcare professionals, patients, and caregivers.
• Collect, evaluate, and record technical product complaints, and report them to the relevant Marketing & Distribution Partner.
• Collect, evaluate, and record pharmacological product complaints, such as Adverse Drug Reactions (ADRs) and Adverse Events (AEs), and report them to the relevant Marketing & Distribution Partner.
• Communicate weekly updates on ADRs and AEs to Marketing & Distribution Partners.
• Submit monthly reconciliation reports on ADRs and AEs to Marketing & Distribution Partners.
• Handle any other duties as required by changes in departmental operations to ensure regulatory compliance.

Minimum Requirements

Job-Related Knowledge

• Pharmaceutical industry laws, regulations, and ethics (Medicines and Pharmacy Acts).
• Marketing codes in the pharmaceutical industry.
• Other industry-related laws, regulations, and ethics (Consumer Protection Act, Companies Act, and Competition Act).
• Business processes for developing promotional materials, new product launches, purchase orders, and stock control.
• Knowledge of pharmaceutical manufacturing, wholesaling, and distribution.
• Understanding of Good Warehousing Practice (GWP), Good Distribution Practice (GDP), and Good Manufacturing Practice (GMP).
• Solid knowledge of pharmacovigilance processes.

Job-Related Skills

• Strong verbal and written communication.
• Problem-solving and analytical thinking.
• Attention to detail.
• Good interpretation skills.
• Ability to maintain meticulous records.
• Effective interaction and communication with diverse groups.
• Relationship-building skills.
• A systematic approach to tasks.
• Excellent IT skills (Microsoft Office suite).
• Teamwork abilities.
• Project management, planning, and organizing skills.
• Record-keeping and document administration skills.
• Policy and procedure development skills.
• Analytical and problem-solving skills.
• Presentation skills.

Job Experience

• At least 3 years of experience in a quality environment within the pharmaceutical industry.
• At least 1 year of pharmacovigilance experience.

Education

• Relevant bachelor’s degree, or
• Equivalent National Diploma (3-year qualification) in Life Sciences, Biotechnology, Chemistry, or similar.

Essential Competencies

• Deciding and initiating action.
• Working with people.
• Adhering to principles and values.
• Relating and networking.
• Writing and reporting.
• Planning and organizing.
• Following instructions and procedures.
• Adapting and responding to change.