QA Specialist and GDP Responsible Person, Finland

Shape the LEO Pharma of tomorrow 

At LEO Pharma, our mission transcends the conventional. We're on an ambitious path to become the leaders in medical dermatology worldwide. You are a motivated Quality professional that will play a key role to ensure the integrity of our LEO Pharma products and is eager to keep up with local regulations to ensure that compliant products are delivered to our patients, and that our inspections are successful– why is this the best job in the world.

In Quality International department we share a “challenge accepted” mindset and are guided by our winning behaviors of simplification, collaboration, and accountability, to achieve our goals.

Your role

The key role for the QA Specialist is to ensure the integrity of LEO Pharma products.  Acting as Responsible Pharmacist in GDP for LEO Pharma Oy in line with Finnish Medicines Act for ensuring that the medicinal products distributed by the wholesaler LEO Pharma Oy meet the requirements defined by EU GDP and Finnish Medicinal Act in regards of procurement and supply. You will join a dynamic team that works across the Nordic region, building strong partnerships and achieving common goals. You will support Global Quality with inspections, projects, and supply set-up. This position is home-based, with periodic travel required within the Nordic region when being located in Finland.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.

•    Quality oversight of affiliates and local market release in the Nordics
•    24/7 availability for critical quality issues and recalls
•    Act as primary quality contact person with distributing wholesaler
•    Maintain local wholesaler license
•    Keep abreast of local regulations, best practices, and maintain inspection readiness
•    Deliver local quality intelligence to global function related to local legislation and requirements
•    Stop the distribution of pharmaceutical products if a serious/critical deviation happens
•    Implement recall procedures and perform mock recall to ensure recall procedures are adequate
•    Approve/reject GDP related change controls, CAPAs and deviations
•    Manage returns: approve any returns to saleable stock
•    Decide on the final disposition of returned, rejected, recalled or falsified products in cooperation with the Principal QP
•    Liaise with customers/stakeholders and local authorities regarding quality matters, including quality defect notifications and hosting inspections/audits and responding to observations
•    Responsible for the approval and qualification of local customers and distributors and their regular review
•    Maintain quality agreements with manufacturers and distributors, when applicable
•    Support audit of distributors and service provider as per global SOPs
•    Monitor global SOP updates and assess local impact, including preparation and development of local SOPs
•    Ensure that self-inspections are scheduled,performed, and necessary corrective measures are implemented
•    Quality complaint handling of Nordic complaings
•    Submit and update Out of stock notifications to Fimea
•    Support free medical sample distribution
•    Local mandatory stock: contact person, responsible for notifications and applications
•    maintenance and development of the Quality Management System (QMS)
 

Your qualifications

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

•    MSc in Pharmacy, registered in Finland
•    5+ years relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance/Quality Control and/or Regulatory Affairs.
•    Fluent English, written and spoken (B2 expected, C1 preferred cfr CEFR system).
•    Experience with competent authority inspections and/or third-party audits.
•    Solid decision-making skills and computer skills.
•    Strong verbal and written communication skills
 

LEO Pharma is built on collaboration, innovation and curiosity. Is this you? Can you bring this and

•    positive attitude,
•    ability to work independently and prioritize with minimal daily instructions,
•    problem-solving capabilities,
•    ability to build relationships within the affiliate and across functions and borders,
•    collaborate effectively to achieve 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 Nordic Quality manager. You will also have a dotted reporting line to the General Manager of LEO Nordic.

 
Your application

 
You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.