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Quality Assurance Expert for Pharmaceutical Manufacturing
1 week ago
Company Overview
Novo Nordisk A/S is a dynamic company that drives change in the pharmaceutical industry. We strive for excellence without fixating on perfection and seize opportunities to develop.
We are responsible for Quality Assurance of Novo Nordisk's local manufacturing CMOs; we currently consist of eight QA colleagues working closely together, covering our operational CMOs in Saudi Arabia, India, Bangladesh, and soon to come South Africa.
Job Description
In this position as Advanced QA, you will work with Contract Manufacturing Organizations (CMOs) located around the world. The objective of the position is to ensure QA oversight by activities such as visits at the CMO, compliance checks, approval of QMS documents, and release of Novo Nordisk insulin products to the market.
You will be responsible for delivering best-in-class Quality Assurance and work with our colleagues in Line-of-Business to ensure the highest quality at our CMOs production.
- You will handle daily operations such as approval of change requests, deviations, and batch release, as well as supporting in all quality matters.
- You will build the Quality mindset as well as Quality and Compliance culture at the CMO.
- You will train the local CMO QA organization to maintain and improve compliant operations.
- You will engage and energize local employees at the CMOs.
Required Skills and Qualifications
We are looking for a colleague who can handle situations independently, apply subject matter knowledge, identify better practices, create improvements to processes, share knowledge, and let colleagues learn and shine.
- You should hold an academic degree within Pharmacy, Chemistry, Biochemistry, Biotechnology Engineering or similar.
- You should have some relevant experience working with either aseptic processes, assembly, or packaging production in organizations within pharmaceutical manufacturing (either as QA or production).
- You should have a high level of knowledge within Quality, QMS, and EU GMP requirements.
- You should have gained said experience within the pharmaceutical or medical devices industry.
- You should be fluent in English, both written and spoken.
