- 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.
- 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
Audits and Inspections Coordinator - Kalundborg, Danmark - Novo Nordisk A/S
Beskrivelse
Are you passionate about ensuring compliance and quality standards? Do you have experience in coordinating audits and inspections? We are looking for a skilled Audit and Inspections Coordinator to join our API Quality Assurance Operational and Business Support team at Novo Nordisk. If you are detail-oriented, knowledgeable about regulatory requirements, and have a strong background in GMP, then read on and apply today for a life-changing career.
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 Coordinator, you will have the following responsibilities:
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:
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.