Quality Assurance Specialist for the Nordic Region - Lysaker, Norge - LEO Pharma

Beskrivelse

Your role

The key role for the QA Professional is to ensure the integrity of LEO Pharma products. This will involve ensuring that the distribution of LEO Pharma products is done according to regulations, and that LEO Nordics (Denmark, Norway, Finland, Iceland & Sweden) is compliant with local legislation and LEO Global procedures. You will support LEO Nordics and the Global Quality organization with oversight audits, inspections, projects, supply set up.

The Quality function maintains quality compliance with Good Distribution Practice (GDP) and LEO Standard Operating Procedures (SOPs), assisting LEO Pharma in meeting financial sales targets and ensuring that quality product is available to patients.

The QA Professional will:

• Act as responsible person for LEO NORDICS (RP) and be the responsible person on the license of LEO Pharma NORDICS.

• Work closely together with the affiliate.

• Act as primary quality contact person with Third Party Logistics (3PL) provider, wholesalers, distributors/third parties in the markets for quality related requests.

• Decide on the final disposition of returned, rejected, recalled, or falsified products in collaboration with the Qualified Person at the manufacturing site.

• Obtain and maintain new competencies and knowledge within relevant quality disciplines and industry trends.

• Make Out of stock notifications to competent authorities.

• Be responsible for updating/maintaining local Quality SOPs.

• Ensure compliance with appropriate SOP's, policies, and guidelines.

• Stop the distribution of products if a serious/critical deviation happens.

• Responsible for the monitoring and management of quality/GDP related matters in the QMS.

• Manage internal audits and external inspections from HA.

• Handle customer complaints.

You could be based at our office in Malmö, Ballerup or Fornebu and be able to work up to 2-3 days a week remotely. Depending on your location, there could be more flexibility. You should be available to travel when needed to the HQ in Ballerup, Nordic countries & 3PL in Netherlands if required.

Your qualifications

To succeed in this role, we anticipate that you have the following qualifications:

• Degree in Life Sciences, B.Sc. in Pharmacy or any other relevant discipline.

• Fluent English, written and spoken (B2 expected, C1 preferred cfr CEFR system).

• 5+ years relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance/Quality Control and/or Regulatory Affairs.

• Experience with competent authority inspections and/or third-party audits.

• Solid decision-making skills and computer skills.

Other Skills

Strong verbal and written communication skills in English are essential. Ability to work independently and prioritize with minimal daily instructions as well a positive attitude and problem-solving capabilities are important. Being able to build relationships within the affiliate, across functions and borders, and work together to achieve the common goals.

Your new team

You will become part of the Global Quality function at LEO Pharma, more specifically part of Quality International, reporting into to the Quality Europe North manager. You will also have a dotted reporting line to the General Manager of LEO Nordic.