Audits and Inspections Specialist

The position In this role, you will be a part of a team that has responsibility of coordinating audits and inspections and follow up on findings afterwards, where you will utilise your in-depth knowledge of compliance, requirements, and expectations from authorities to ensure the right level of compliance in the supply of active pharmaceutical ingredients. You will also respond to complex compliance questions and be responsible for coordinating, planning, and follow up on inspections and audits. As an Audit and Inspections Specialist, you will have the following responsibilities: Coordinate and contribute to planning and conducting audits and inspections (on-site, remote and paper-based), as well as providing answers to audit findings and inspection observations and a number of other requests from authorities. Being proactive in identifying needs for upcoming qualification audits in PS API. Help driving the cross-functional support group for audits and inspections in PS API. Contribute to coaching and sparring of employees to ensure a strong understanding of compliance with GMP requirements. Act as a sparring partner for PS API and PS API Quality Assurance regarding GMP. Moreover, you will be a specialist in your own area of expertise and act as a mentor for upcoming specialists or those needing guidance. Qualifications To succeed in this role, you should have the following qualifications: A master’s degree in pharmacy, science, engineering, or similar Several years of experience working with compliance Several years of experience in the pharmaceutical industry, API, quality control (QC), and/or quality assurance Strong GMP knowledge, ability to follow current GMP development and relevant literature, as well as extensive knowledge and experience in quality assurance work Good stakeholder management skills Strong communication skills Fluency in English, both written and verbal As a person, you are good at acquiring new knowledge and have a desire to teach and disseminate knowledge. It is expected that you have strong business acumen.Furthermore, you have excellent communication skills with the ability to collaborate, both with internal and external stakeholders. About the department You will join the business area of API Quality Assurance Operational and Business Support, which is a part of API Quality. Within this area, you will be a part of the department that drives projects, strategy, audits, and inspections, as well as IT, digitalisation, QA for QC & Manufacturing Development and much more. Our purpose is to set direction within our area of expertise and enable API Quality Assurance to meet our goals.As a group, we get energy from solving problems, seeing opportunities, and driving impactful change. We focus on development while having fun at the same time; we are maintaining a social work environment with a high level of engagement. Our ambition is to provide world-class support to our key stakeholders, and we take pride in delivering on our commitments. Working at 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, employees. Together, we go further. Together, we’re life changing.