Lead Auditor

Lead Auditor - Senior Quality Compliance Specialist

Category: Regulatory Affairs

Country/Region: DK

Location: Odense, DK, 5260 Søborg, DK, 2860

Are you passionate about GMP auditing and quality while being eager to travel worldwide to audit our suppliers and partners? Then this position might be a great opportunity for you

About the job
In this position, you will take the role as Lead Auditor in our dedicated team of auditors and highly skilled Quality Specialists ensuring compliance of our portfolio of Pharmaceutical Contract Manufactures by auditing against the EU GMP EudraLex Volume 4 regulation.

Furthermore, as a team member, you will have the responsibility to approve and maintain the approval of suppliers, quality documentation and systems. You will also support our Quality Operations and Product Quality organisations with high level of quality to release products from suppliers in compliance with GMP.

Your key responsibilities and primary tasks include:

1. Prepare, perform and follow-up on audits of Pharmaceutical Contract Manufactures, Laboratories, Packaging Manufactures, Warehouses, and API Manufacturers.
2. Assessment and approval of quality and audit documentation from Contract Manufacturers, Laboratories, and API manufactures.
3. Take part in assessing and follow-up on our supplier oversight to maintain supplier approval status.
4. Take part in ongoing improvements of processes and procedures in the Pharmaceutical Quality System with the team and cross-functional working groups.
5. Support our group of QA Specialists releasing products to the market.

In this position, you will report to Lead Auditor & Department Manager, Merete Bülow Ravens. The position requires expected travel activities of approximately 50-60 days per year with destinations within and outside of Europe.

Who are you?
We are looking for an experienced candidate with a positive approach to meet challenges and changes. Additionally, we are also seeking someone who possesses strong analytical skills and who thrives when assessing data, objectives, and documentation.

As a person, you are a collaborative team player who appreciates working with all levels of colleagues, across teams and functions both within and outside the organisation.

As an auditor, you are accommodating, have a pronounced situational awareness and a clear understanding of different cultures. Furthermore, you are robust, persistent, and vigorous in the audit situation. You are oriented towards reaching results and aiming to keep deadlines with a high level of quality and compliance.

Additionally, we expect you to:

1. Hold a master’s degree in Pharmacy, Chemical Engineering, Chemist, Biochemist or similar.
2. Have solid experience and knowledge from auditing in the Pharmaceutical industry towards the EU GMP Eudralex Vol. 4.
3. Be experienced within audit and supplier management processes and in supporting audits/authority inspections.
4. Professional proficiency in Danish and English which allows you to ensure great communication with suppliers and auditees.

Who are we?
Our team, as a part of the Quality Management Department, consists of 12 dedicated colleagues handling the above-mentioned portfolio of tasks related to OTC and Rx Specialty pharmaceutical products. Based on the recent growth and rapid development, we need an additional colleague to handle the expanding portfolio and to further drive our ambitions.

In the office, we appreciate the informal and positive atmosphere where there is room for laughter and seriousness.

Why should you work for Orifarm?
At Orifarm, we know that our growth comes from the development of our employees. We are an ambitious organization with an entrepreneurial culture celebrating can-do attitudes, smarts, and hearts. Our secret to success? Valuing how different skill sets join forces to make our journey happen.

You will experience a work environment characterized by flexibility and a strong commitment to work-life balance, understanding that the best results come from satisfied and well-supported employees. Our international setting offers great opportunities for growth and career advancement. Additionally, you can enjoy a great canteen with various delicious and healthy meals at our offices and take advantage of the massage service available at our office in Odense. We also prioritize social events and gatherings ensuring our employees feel connected and engaged with each other.

We regard our feedback culture as a fundamental element in the individual employee's opportunities for learning and development.

Lastly, when we have good results, every employee, including student workers, is part of our bonus scheme.

About Orifarm
Everyone should have access to modern medicine. High costs or lack of access to pharmaceuticals should never impact our possibility to receive treatment or relief and live a healthy life. At Orifarm, we aim to bring healthy days by making modern healthcare a better deal for the people and the societies we serve. Working towards our vision, we create access to affordable, high-quality pharmaceuticals and healthcare products by challenging markets and always seeking new opportunities. With our core values paving the way, we always act responsibly and constantly with our customers at the center of our attention. And everything we do is driven by our sole purpose:
For as many as possible, as healthy a day as possible.

Our history goes back to 1994 when Orifarm was founded in Denmark by Hans and Birgitte Bøgh-Sørensen. Since then, Orifarm has grown from a small nine-person company into an international company operating globally in 15 countries. Today, Orifarm is Europe's largest parallel importer of pharmaceuticals and Denmark's largest supplier of pharmaceuticals, with more than 2,200 employees.

We encourage everyone to apply
At Orifarm, we welcome people from all backgrounds, recognizing that the best outcomes come from a diverse and inclusive workforce and environment. Our commitment is to create an environment where different perspectives and skills drive innovation and contribute to a sustainable and inclusive future. By creating such an environment, we are confident that we can achieve exceptional results together.

Job Location
Location Odense or Søborg – Work on the distance is an option.

Need further information?
If you need further information about the job, please contact Lead Auditor & Department Manager, Merete Bülow Ravens at

Application deadline
As soon as possible.

#J-18808-Ljbffr

---