Quality Assurance Specialist 1451

Quality Assurance Specialist

For you that thrive on working with quality from an operational perspective with a focus on both quality and commercial perspectives.

We are looking for a Quality Assurance Specialist to join our Innovation & Launch team someone who enjoys taking on significant responsibility and working crossfunctionally and projectbased. As a specialist in the team you will thrive in an environment marked by high professionalism and sharp prioritizations where we ultimately need to ensure that products hit the market at the correct time.

About the Job

As a QA specialist focusing on tech transfers you will help ensure that Orifarm succeeds in bringing tech transfer products to market with the right quality and at the right time. Your primary task is to ensure alignment with the project organization that manages Tech Transfers and to ensure that quality requirements from qualification to product launch are managed.

The position is a hub between quality and the commercial side of the business so it is crucial that you can meet commercial needs while ensuring that the process proceeds according to current GMP requirements.

Tasks may therefore include:

• Participating in project meetings with various stakeholders both in QA the project organization and the commercial side of the business.
• Review and approval of e.g. API audit reports risk assessment on excipients EI/Nitrosamines AMT validation documentation master batch records and journals as well as stability testing.
• Acting as a sparring partner for our manufacturers during product transfer manufacturing as well as an internal sparring partner for the commercial side of the business.
• Handling change controls and identifying tasks that need to be performed in connection with a tech transfer process.
• Creating deviations in connection with tech transfer of products production and launch.
• Participating in and supporting the development of new procedures related to the above tasks.
• Releasing launch products to the market.
• Preparing and negotiating quality agreements with manufacturers in connection with the tech transfer of products.

Who Are You

You will be part of a team with many dedicated colleagues so it is important that you thrive in an environment where we work at a high pace and where priorities can shift depending on market needs. You are independent and enjoy taking responsibility for your own areas and tasks. You thrive on and have experience working projectbased and keeping your stakeholders updated. You enjoy a social environment where there is room for both laughter and sparring.

Additionally we expect that you:

• Can work structured with attention to detail and thrive on following SOPs.
• Are proficient in English both spoken and written.
• Have a relevant educational background at the masters level such as a pharmacist biochemist biomedical scientist or similar.
• Experience from a similar industry is preferred but not a must.

Who Are We

In our department we have an informal and positive tone where there is room for both laughter and seriousness. Our good cooperation is characterized by each of us taking responsibility for our own areas but also helping each other in a busy and exciting day. There are various tasks in the team where the individual specialists have their core competencies and there is always room for sparring in the team.

The team is part of QA operations a growing area with approximately 100 employees in total. The primary goal of the department is to ensure the operation of our products from launches to handling complaints from the market and we highly value crossteam sparring.

About Orifarm

Everyone should have access to modern medicine. High prices or lack of access to medicines should never affect our ability to receive treatment or relief and live a healthy life. At Orifarm we strive to bring healthy days to the people and communities we serve by making modern medicine a better business for the people and communities we contribute to. Based on our vision we aim to provide access to affordable highquality medicines by challenging markets and always seeking new opportunities. With our core values at the forefront we always focus on responsibility and our customers as the center of our attention. Everything we do is driven by our single purpose:

For as many as possible as healthy a day as possible.

Our history dates back to 1994 when Orifarm was founded in Denmark by Hans & Birgitte BghSrensen. Since then Orifarm has grown from a small nineperson company to today being an international company operating globally in 13 different countries. Today Orifarm is Europes largest parallel importer of pharmaceuticals and Denmarks largest supplier of pharmaceuticals with over 2200 employees.

We operate within seven different business areas: Over the Counter (OTC) Consumer Healthcare Generics Promotional Rx Unlicensed Medicines Parallel Import and Clinical Trials Supplies (CTS). Additionally we focus heavily on new business opportunities and synergistic M&A to further enhance our offerings.

We Offer

At Orifarm we know that our growth is rooted in the growth of our employees. We are an ambitious organization characterized by an entrepreneurial culture and we celebrate both brains and hearts with a cando attitude. Our secret to success Appreciating how different skills can play together so we collectively create the framework for the journey. Whether you play a direct or indirect role in achieving our goals you will contribute by using your skills both personal and professional. At Orifarm your personal growth journey will be shaped by your own contribution to making everyday life healthy for as many as possible.

We consider our feedback culture as a fundamental part of every employees opportunity for learning and development. And when we achieve good results together all employees including student assistants are of course part of our bonus scheme.

Location

You will primarily have your daily work at Orifarms site in Lyszkowice (Lodz Voivodeship) Poland. We emphasize a flexible workday where all employees have the opportunity to work from home two days a week if desired by the employee and it aligns with the tasks at hand.

Need Further Information

If you need further information please contact Karina Dalgaard Hansen at

We are often looking for new employees who can contribute to our growth so we may have other opportunities that are interesting for you Follow us on LinkedIn and receive updates about our business and job opportunities:LinkedIn

Application Deadline

As soon as possible.