Quality Assurance Assistant

Clicks Group; Cape Town; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A leading pharmaceutical company in Cape Town is seeking a QA Assistant to join their team. This role involves ensuring regulatory compliance of printed materials, liaising with various stakeholders, and maintaining meticulous records. Candidates should possess a relevant degree and significant experience within the pharmaceutical quality environment, including knowledge of pharmacovigilance. Strong verbal communication skills and attention to detail are essential for success in this position.

Benefits

Market related remuneration

Career development opportunities

Qualifications

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

Responsibilities

• Liaise with internal agencies and partners for timely delivery of printed material.
• Manage project tools ensuring timely delivery on commercial expectations.
• Communicate technical product complaints to relevant partners.

Skills

Verbal and written communication

Problem solving and analytical thinking

Attention to detail

Teamwork

Excellent IT skills

Education

Relevant bachelor’s degree

Equivalent National Diploma in Life sciences

Tools

Microsoft suite

Job description

Position Summary

Industry: Wholesale & Retail Trade

Job category: Pharmaceutic

Location: Cape Town

Contract: Permanent

Remuneration: Market related

EE position: Yes

About Our Company

Clicks Group

Introduction

We are looking to employ a QA Assistant to work within the United Pharma Marketing division of our business. The role will be based at our Head Office and report to the Regulatory Affairs Manager.

Job Description

Job Objectives

• To liaise with the Clicks in‑house advertising agency (BTB) and Marketing & Distribution Partners and their Suppliers / Manufacturers to ensure timely compilation and accurate delivery of all printed material, ensuring accurate compilation and proofreading of all PI’s, PIL’s and product packaging artwork according to prescribed SOPs to ensure legal regulatory and marketing code compliance for all such partners and as detailed in the relevant Technical Quality Agreements (TQAs) with such partners.
• To timeously deliver regulatory compliant marketing, promotional and/or educational material required through effective communication and proactively managing and ensuring delivery with all stakeholders effectively utilising and coordinating logistics and resources.
• To liaise with multiple stakeholders to ensure products are listed on all applicable internal and external IT systems according to project deadlines.
• To create and manage project management tools (trackers) ensuring accurate and timely delivery on commercial expectations.
• To apply good document management practices to ensure regulatory legal compliance (e.g. traceability and version control).
• To keep all filing of advertising and marketing (printed) material up to date.
• To keep abreast of new pharmaceutical and regulatory trends, specifically pertaining to advertising and marketing (printed) material intended for use by healthcare professionals as well as patients and caregivers.
• To collect, evaluate and record technical product complaints and communicate such events to the relevant M&D Partner.
• To collect, evaluate and record pharmacological product complaints (Adverse Drug Reactions [ADRs] and Adverse Events [AEs]) and communicate such events to the relevant M&D Partner.
• Communicate weekly (Adverse Drug Reactions [ADRs] and Adverse Events [AEs]) to M&D Partners.
• Submit monthly (Adverse Drug Reactions [ADRs] and Adverse Events [AEs]) reconciliation reports to M&D Partners.
• Any other duties as per changes in operational requirements of the department to deliver Regulatory compliance.

Minimum Requirements

Job related knowledge

• Pharmaceutical industry laws, regulations and ethics (Medicines and Pharmacy Acts)
• Marketing code related to pharmaceutical industry
• Other Industry related laws, regulations and ethics (CPA, Companies and Competition Acts)
• Business processes pertaining to development of Promotional material, New Launch Activities, Purchase orders and stock control
• Knowledge of Pharmaceutical Manufacturing, Wholesaling/Distribution
• Knowledge of GWP/GDP/GMP
• Solid knowledge of Pharmacovigilance processes

Job Related Skills

• Verbal and written communication
• Problem solving and analytical thinking
• Attention to detail
• Good interpretative skills
• Ability to keep meticulous records
• Ability to interact and communicate effectively with a wide range of people
• Relationship building skills
• A systematic approach to tasks
• Excellent IT skills (Microsoft suite)
• Teamwork
• Project management, planning and organising 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 working experience in a quality environment within the pharmaceutical industry
• At least 1 year Pharmacovigilance experience

Education

• Relevant bachelor’s degree, or
• Equivalent National Diploma (a 3‑year qualification) in Life sciences, Biotechnology, Chemistry etc.

Essential Competencies

• Deciding and Initiating Action
• Working with People
• Adhering to Principle and Values
• Relating and Networking
• Writing and Reporting
• Planning and Organising
• Following Instructions and Procedures
• Adapting and Responding to Change