Quality Assurance Assistant

Clicks Group Limited

Cape Town

On-site

ZAR 279,000 - 390,600

Full time

14 days+

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Job summary

A leading pharmaceutical company is seeking a QA Assistant to work within their United Pharma Marketing division. This role involves ensuring compliance with regulatory standards, liaising with stakeholders, and managing project timelines effectively. The ideal candidate will have at least 3 years of experience in a quality environment within the pharmaceutical industry and strong problem-solving skills. This position is based at their Head Office in Cape Town.

Qualifications

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

Responsibilities

Liaise with stakeholders to ensure compliant marketing and educational material.
Create and manage project management tools for timely delivery.
Keep up to date on pharmaceutical regulatory trends.

Skills

Problem solving and analytical thinking

Ability to keep meticulous records

Effective communication

Excellent IT skills (Microsoft suite)

Project management

Job description

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 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 forall 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.

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

· SolidknowledgeofPharmacovigilance processes

Job related skills:

· Problemsolvingandanalytical thinking

· Abilitytokeepmeticulous records

· Abilitytointeractandcommunicate effectivelywithawiderangeof people