Quality Specialist at Novo Nordisk

Your new position

• As a Quality Assurance Specialist at Novo Nordisk, you will manage the product quality complaints system which includes collection and reporting of safety/technical complaints, coordinate complaint unit collection and shipment to the investigating site and tracking status and communicating outcomes.

Other responsibilities will include:

• Leading on the annual APR activities including obtaining, securing reviewing, reporting on Quality trends/concerns including ongoing stability programs
• Managing the product quality complaints system which includes collection and reporting of safety/technical complaints, coordinate complaint unit collection and shipment to the investigating site and tracking status and communicating outcomes
• Third party suppliers: Ensure annual mock recalls are conducted with distribution partners and reconciliation accurately reflect partners recall capabilities, conduct supplier audits at third parties when needed and manage third-party suppliers with potential impact on the QMS by assessing supplier risk and providing risk-based input to address business risks
• Maintaining and updating local QMS procedures in compliance with cGMP/cGDP and ensure correct documentation control and ensure the necessary approval for archiving documents for the Quality unit and approval of destruction of archived documents in line with global archiving procedures and systems
• Supporting in monthly monitoring of change control/CAPA/effectiveness and assist with deviation/change approvals as applicable and manage monthly external regulatory changes affecting the affiliate QMS and work cross functionally with stakeholders to ensure full compliance to regulatory requirements
• Supporting QMR activities including data set collection from all departments and follow-up on implementation of QMR top risk actions and support in driving quality performance and quality culture initiatives (e.g., World Quality Day, quality communications, KPI reporting)
• Driving and implementing the local training process for the affiliate and ensure that a local training strategy is in place, is effective and is continually maintained to ensure ongoing compliance to procedural requirements
• Supporting product release processes including preparing batch release documentation and working with Quality Control laboratories for post import testing analysis.

Your new department

• Join our dynamic Legal, Ethics, Compliance and Quality (LECQ) team in South Africa, where we are committed to maintaining the highest quality standards in everything we do. Our department is dedicated to ensuring compliance and driving quality improvements across the organisation. We foster a collaborative and supportive atmosphere, where your contributions will make a significant impact on our mission to deliver life-changing products to patients around the world.

Your new skills and qualifications
You should possess a Pharmacist degree and are a registered pharmacist in South Africa, with the following qualifications:

• Experience in quality assurance, preferably in the pharmaceutical industry between 3 to 5 years
• Strong understanding of SAHPRA and Pharmacy Council regulations.
• Excellent communication and organisational skills.
• Ability to manage multiple tasks and meet ambitious deadlines.
• Experience with Quality Management Systems (QMS)
• Familiarity with supplier quality management
• Strong analytical and problem-solving skills.
• Demonstrated knowledge of ICH, GWP, GCP, GMP and other relevant regulations
• Understanding the quality principles of ISO (ISO 9001 and 13485 among others)
• Experience / involvement in audits (health authority inspections) is preferred
• Experience in working with a cross functional team and international teams preferably in a GxP function
• Strong business acumen and business partner mindset