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Senior API/Raw Material Quality Specialist  

Leo Pharma (company)

Posted on : 08 May 2017

Project Description

Senior API/Raw Material Quality Specialist

Do you have a strong quality mind-set? Do you have interest in and experience with API/Raw materials within the pharmaceutical industry? Do you have experience with cooperation with 3rd parties?

Then you may be the Senior API/Raw Materials Quality Specialist we are looking for in “Patient Supply and Suppliers Quality”.

Patient Supply and Suppliers Quality (PSSQ)

The PSSQ department is a global department at LEO Pharma, responsible for handling of all GPS (Global Product Supply) suppliers of API’s, packaging materials, raw materials, and excipients. Furthermore, the department is responsible for supporting Distribution Management, including 3PLs and freight forwarders, and Customer Order Management. The department is involved in approval of new suppliers and distributors, setting up quality agreements, preparing audit plans, performing audits and developing partnerships with suppliers and distributors.  Also the department is involved in day-to-day operations such as change controls, deviations etc.

Our global department comprises of 5 enthusiastic colleagues located in Ballerup (Denmark), Dublin (Ireland) and Vernouillet (France). This position is located in Ballerup.

PSSQ is part of Global Quality with over 170 employees worldwide.

As our new Senior API/Raw materials Quality Specialist your primary responsibilities will be:

  • Planning, performing and follow up on audits of API and Raw material suppliers
  • Establish and maintain Quality Agreements (API´s and Raw materials)
  • Evaluation and risk assessments of API´s and Raw material suppliers
  • Quality support to our internal stakeholders at LEO Pharma
  • Establish and maintain API/Raw material Standard Operating Procedures

Your profile:

  • You have a master degree in one of the natural sciences (e.g. pharmacy, engineering)
  • You have a minimum of 5 years’ experience from the pharmaceutical industry and a strong quality mind-set
  • You enjoy working with high complexity and having many things on your plate
  • You have experience working with suppliers and/or external partners
  • Experience as an auditor is a plus but experience from pharmaceutical manufacture or quality operations can also be the starting point
  • You enjoy working together with people from different cultures and understand that there may be more than one compliant solution
  • You are pragmatic and enjoy finding value adding solutions
  • You are able to travel up to 30 days per year worldwide
  • You have great communication skills, both oral and written. You master English on a negotiation level.

We look forward to welcoming you to our global team.