Lead Auditor – Senior Quality Assurance Specialist
Are you passionate about quality and GMP while you are eager to travel World Wide to audit our suppliers and partners? Then this open position as Lead Auditor in the our audit team is 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 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 and to support our Product Release Team with high level of quality to release products in compliance with GMP.
As a Lead Auditor and Senior Quality Specialist the key responsibilities and primary tasks includes:
- Planning and performing of audits of Pharmaceutical Contract Manufactures, Laboratories, Packaging Manufactures and API manufactures. The position requires expected travel activity around 35 – 40 days per year with destinations within and out of Europe.
- Assessment and approval of quality documentation from Contract manufactures and laboratories.
- Take part in ongoing improvements and maintenance of the Pharmaceutical Quality System with in the responsibility of the team and in cross-functional working groups of specialists
- Take the role as SME and trainer with in different professional areas to support colleagues
- Support to our group of QA Specialist releasing products to the market
Who are you?
You hold an open mindset to meet challenges and changes. You are in possession of strong analytical skills and you thrive in the work with assessing data, objectives and documentation. You are a collaborative team player who appreciate working with all levels of colleagues, across teams and functions both within and outside the organization.
As an auditor you are accommodating, have a pronounced situational awareness and a clear sense for culture-understanding. Further, you are robust, persistent, and vigorous in the audit situation. You are oriented towards reaching results and aiming to keep deadlines with high level of quality and compliance.
Additionally, we expect you to:
- Hold a Master´s degree as Pharmacist, Checmical Engineer, Chemist, Biochemist etc. and possess knowledge of auditing towards the EU GMP Eudralex Vol. 4
- Have relevant experience from the Pharmaceutical industry (as QA, QC and/or production)
- Be experienced within auditing or supporting audits/authority inspections
- Hold professional communications skills for robust communication with suppliers and auditees
Who are we?
Our team consists of 8 dedicated colleagues handling the above-mentioned portfolio of tasks related to OTC and Rx products. Based on the recent growth and rapid development, we need an additional colleague to handle the expanding product portfolio and to further drive our ambitions.
We are located in the Orifarm Headquarter in Odense. In the office, we appreciate the informal and positive atmosphere where there is room for laughter and seriousness.
Starting out with a strong entrepreneurial mission, Orifarm was founded in 1994 by Birgitte and Hans Bøgh-Sørensen. The underlying explorer spirit still characterizes the company, and with high ambition, we are constantly looking for new opportunities and business areas to invest in. Our purpose of being is to create competition and provide important savings for society and to ensure better value for money for consumers. We strive to make this happen while insisting on being good colleagues, improving together, helping each other, and innovating.
We operate within seven business areas: Over the Counter (OTC), Consumer Healthcare, Generics, Promotional Rx, Unlicensed Medicines, Parallel import and Clinical Trials Supplies (CTS). We are the largest parallel importer of pharmaceuticals in Europe as well as the largest supplier of pharmaceuticals in Denmark. We hold a strong position in Generics in the Nordics, being the largest producer of over-the-counter medicine in Denmark, and our portfolio contains many well-known brands. Moreover, within New Bizz, we aim to expand our business by exploring new opportunities within pharmaceuticals.
In Orifarm we place great emphasis on both your professional and personal development and on giving you the opportunity to bring all of your skills into play.
We offer a competitive compensation and benefits package and our staff canteen offers a variety of healthy menus every day. Physiotherapy will also be at your disposal.
Interviews are being held on a rolling basis, since we wish to find the right match as soon as possible. If you have further questions about the position, you may contact Department Manager Merete Bülow Ravens +45 22 23 57 83.
Application deadline:As soon as possible