Quality Analyst

6 months ago

Johannesburg, South Africa Novo Nordisk Full time

Quality Analyst

**Category**:Commercial Marketing**Location**:Johannesburg, Gauteng, ZA-
- This position will be based in Rivonia, South Africa, under the Legal & Compliance department. You will directly report to the Director of Legal & Compliance.**The Position**
- As a Quality Analyst, you will be ensuring quality assurance of outsourced and License Manufacturing of semi-finished and finished drug products. In addition, you will be conducting audits, monitoring processes, and determining the quality of outputs against defined internal or regulatory standards. Moreover, you will ensure that retention samples received from the manufacturer meet regulatory requirements for each locally manufactured batch and that the retention samples are retained at the affiliate for the regulated time frame.- Your main accountabilities will be:
- Developing and maintaining an accurate filing system for local product batch release information, reporting on process deviations and defects, and providing recommendations for improvements
- Collaborating with suppliers and vendors to negotiate service-level agreements and ensure contractual obligations are met
- Assessing potential risks for patients and products and offering advice and recommendations
- Perform due diligence check on relevant Batch Manufacturing and Packaging Records for locally manufactured Products, according to regulatory requirements
- Manage the handling of counterfeit processes for the affiliate which include logging of new cases, follow-up, and reporting of cases to the Health Authority and Global Security

**Qualifications**
- As a Quality Analyst, you need to have continuous further education in quality assurance, Good Manufacturing Practice (GMP), and Good Distribution Practice (GDP). Nevertheless, you need to have experience in handling deviations and change requests.- To be successful in this role:
- A degree in pharmacy or a relevant technical/scientific field.
- A minimum of 2 years’ experience in quality assurance and production.
- Experience in handling deviations and change requests.
- Strong attention to detail and a quality mindset.
- Proficient in prioritization and execution of activities.
- Excellent communication and stakeholder management skills.
- Strong inter-cultural understanding.

**About the Department**
- The Quality Analyst position is based in Rivonia, South Africa. You will be part of the local quality team, working closely with the Legal & Compliance Director and the Responsible Pharmacist. Our team is dedicated to ensuring compliance with regulatory requirements and maintaining high-quality standards for Novo Nordisk products in the South African market. We value collaboration, attention to detail, and continuous improvement in our work.**Working at Novo Nordisk**
- At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales - we’re all working to move the needle on patient care.**Contact**Deadline**- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.- At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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