Qualified Person

Afrox, a Linde company

Qualified Person

Germiston, GP, South Africa | req33668

What you will enjoy doing

• Being part of a team of Qualified Person (QPs) whose prime responsibility is to conduct prospective batch certification of all licensed medicinal products on a daily basis, at times throughout the day to suit the needs of the business, this will require batch certification outside of normal business hours
• You will work closely with both manufacturing (Operations and Production) and distribution (Transport and Supply Chain) teams, at both a management and site level, to ensure all relevant GxP activities are compliant with the relevant legislative and Group requirements
• Working closely with the Regulatory Affairs Manager to provide support for all license submissions will be required of you
• Working closely with the Responsible Pharmacist to assist in the review and follow-up of complaints taking into account root causes and provision of any training needs identified will be high on your agenda
• Additionally, you will participate in the external GxP audits of licensed GxP sites, including regulatory inspections
• Lastly, you will be assisting in the development and review of validation documentation, such as Quality Risk Assessments relating to both new projects and/or changes to existing installations used in the manufacture of Region Africa’s licensed medicinal gas products

What makes you great

• You possess a University Degree in Chemistry, Pharmacy, Chemical Engineering or equivalent scientific discipline
• 5-7 years of experience in pharmaceutical/medical gases manufacturing is required
• Knowledge of Good Manufacturing Practice (GMP) regulations for medicinal products for human use is required
• Knowledge of Good Distribution Practice (GDP) regulations for medicinal products for human use is a requirement

Why you will love working with us

Afrox is a market leader in gases and welding products and part of Linde. Integrity, compliance and ethics are driving forces behind our dealings with customers. Afrox employees take pride in what they do and turn every challenge into an opportunity.

What we offer you!

At Linde, the sky is not the limit. If you’re looking to build a career where your work reaches beyond your job description and betters the people with whom you work, the communities we serve, and the world in which we all live, at Linde, your opportunities are limitless. Be Linde. Be Limitless.

Have we inspired you? Lets talk about it

We are looking forward to receiving your complete application via our online job market.

Any designations used of course apply to persons of all genders. The form of speech used here is for simplicity only.

The employment decision shall be informed by the Employment Equity Plan of the company. It is the company’s intention to promote equity (race, gender and disability) through the filling of this post(s) with a candidate whose transfer / promotion / appointment will promote representatively in line with the numerical targets as contained in our Employment Equity Plan. The company reserves the right to withdraw posts, if by doing so, the interests of the Company will be best served.

Afrox, a Linde company acts responsibly towards its shareholders, business partners, employees, society and the environment in every one of its business areas, regions and locations across the globe. The company is committed to technologies and products that unite the goals of customer value and sustainable development.