Quality Assurance Assistant at 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 / Manufactures to ensure timeous 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 SOP's 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)
• Good interpretative skills
• 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