Senior QA Profesional - Måløv, Danmark - Novo Nordisk A/S

Beskrivelse

Are you passionate about setting direction within emerging technologies and ensuring compliance? Do you have experience within Quality Control? Are you skilled in navigating complex stakeholder landscapes and motivating teams to deliver great results? Do you thrive in a constantly changing environment with various challenges and growth opportunities to handle?

If so, we have an exciting opportunity for you.

The Position
In close cooperation with your colleagues, you act as a QA for QC servicing our QC laboratories. You contribute to finding solutions for ad hoc questions and challenges within compliance of QC laboratories. You have a risk-based approach to the quality control process and product, and you contribute to find the right balance between patient safety, compliance to requirements and effective business conduct.

Key responsibilities include:

• Approving the documentation needed for the operation of the laboratories such as change requests, deviations, and SOP's.

• Assisting your colleagues in ensuring the qualification of laboratory equipment and validation of methods for analyzing drug products for the market is compliant with internal and external requirements.

• Ensuring our continuing high level of audit and inspection readiness, with a focus on QA oversight, which entails proactively working with your colleagues to identify areas where our compliance can be strengthened.

Qualifications
To succeed in this role, you have:

• Master's degree as pharmacist, engineer or similar

• Extensive background from a pharmaceutical or medical device organization, where you have gained a solid and up-to-date knowledge of quality and GMP requirements.

• Thorough knowledge within analysis validation, analysis equipment qualification, project management, as well as laboratory computer system validation. CMO (contract manufacturing operations) is a plus.

• Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment while challenging the status quo.

• Fluency in both English and Danish.

The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level, make decisions and follow-up on quality related problems. You are a self-motivated and independent person with a high level of responsibility and initiative who can prioritize your various tasks.

You enjoy working in a dynamic environment, where teamwork is essential, and you like collaborating with many different stakeholders – internally and externally.

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

About the department
Emerging Technologies QA is a new area within Novo Nordisk, we employ approximately 100 employees and we are still growing. We work with assuring quality and compliance of the facilities, the equipment, QC lab, manufacturing development as well the release of tablets and future emerging technologies products for the market.

You will become part of a great QA department (Emerging Technologies QA New Entry & Support), with many interfaces around the organization. The department consists of around 30 people divided into four teams. This position is in the QA for Quality Control team, that consists of 6 highly knowledgeable and skilled people, covering the diverse area of Quality Control.

In the department, we embrace challenges as opportunities. We have a vibrant and positive working environment, good values and exchange of knowledge and experience. We all work towards continuously improving our competences, as well as making work processes more efficient and effective.