Adv QA Professional for Manufacturing Development

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Gentofte

Are you motivated to work with implementation of new products and cover life cycle management of our existing products in Biotech and are disease (BRD) Do you want to be part of a positive and committed team, where we help each other with various exciting tasks? If you are curious about us, and who your new manager might be, don’t hesitate to give Line a call at +45 30798581

About the department

The Quality Assurance (QA) department in BRD has a wide scope, and many interfaces around the organisation, as we are an integrated part of projects concerning new and existing products, digitalization, innovation, and automation, providing the opportunity to impact the future state of the organisation. We are divided into three teams, and this position is in the QA for Manufacturing Development team, which consists of 12 fantastic and skilled employees.

The team has a high level of self-governance, and our working relations are informal as we value good humour and an open and honest culture. We appreciate a colleague who takes responsibility, has a positive and curious approach to new challenges, and who contributes to a positive atmosphere. We are convinced that this is the key to creating good results.

The position

You will play a crucial role in ensuring the quality, patient safety and compliance of our products and for new products to benefit patients with a wide range of chronic diseases. The working assignments are versatile and cover the review and approval of several types of GMP and non-GMP documentation, oversight of quality processes through presence in the facilities and setting direction on quality issues.

  • QA responsible in process groups, Life Cycle Management (LCM) groups for existing products
  • QA responsible for the transfer of new products from CMC to production.
  • QA tasks for development laboratories
  • Approval of stability studies and submission to regulatory authorities
  • Approval of Science and Risk-based validation, change requests, deviations, SOPs etc.
  • Approval of batch documentation, status assignment and CoAs for support proteins
  • Approval of in process control, Master formulas, compatibility, comparability, shelf life, specifications, customer complaints, Site master files (SMF), product specific requirements.
  • Prepare and approve sampling plans and specifications in LIMS.

Qualifications

To succeed and thrive in this position, you have:

  • Master’s degree in pharmacy, microbiology, chemical, engineering or similar.
  • Minimum 3+ years of experience with GMP.
  • Flair for clear and correct communication, even when the message is not easy.
  • Good coordinating- and collaboration skills.
  • Full proficiency in English.

As a person:

  • You take responsibility, work independently, and make decisions that balance quality demands, authority expectations, and business needs.
  • You are flexible and have a strong quality mind-set combined with the ability to decrease complexity.
  • You have a curious, innovative, and solution-oriented approach to overcoming challenges.

Working in Novo Nordisk

Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing.

Contact

If you want to know more, please call Associate Manager Line Lilleøre +45 30798581.

Deadline

November 12th 2023

Feel free to submit your application in Danish or English. Please note that applications will be reviewed continuously, and interviews will be planned as soon as suitable candidates have been identified.

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.


Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Gentofte.

Jobbet er oprettet på vores service den 18.10.2023, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Øvrige
  • Gentofte

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