Qualified Person (QP)
TFS, Sweden

This is six months contract with possibilities for extension and a client-based position to one of our biggest pharmaceutical clients.

The Qualified Person within the company has to be approved by the Medical Products Agency. The QP acts as Qualified Person as well as Responsible Person.

The QP is responsible for

• Company compliance with granted wholesaler’s licence, LVFS 2014.8 and current version of EU GDP
• Company compliance with granted manufaturer’s licence LVFS 2004:6/2004:7 and current version of EU-GMP
• Company compliance with granted authorization to handle narcotics and LVFS 2011:9/2011:10
• Company compliance with our global Pharmaceutical Quality System

• Act as Qualified Person with the authority to be the main contact and represent company in all quality and GDP/GMP related interactions with the Medical Products Agency
• First contact person at company in, and responsible for, general product quality related issues
• Responsible for the product release (all medical products and batches of IMP and CUP material not distributed centrally) of batches to the market, after certification of the EU-QP. The QP is the final decision maker regarding batch releases and has the authority to decide if a batch of medicinal products should be released to the Swedish market or rejected
• Responsible for ensuring that a quality management system is implemented and maintained
• Responsible for ensuring the management of authorized activities and the accuracy and quality of records
• Responsible for ensuring that initial and continuous training programs (related to product quality, GDP and GMP) are implemented and maintained.
• Responsible for coordinating and promptly performing any recall operations for medicinal products
• Responsible for ensuring that relevant customer complaints are dealt with effectively
• Responsible for ensuring that suppliers and customers are approved

Requirements

• Master of Pharmaceutical Science or equivalent
• Minimum 2 years of professional experience within the area of medicinal product manufacturing (production, quality control or quality assurance) or equivalent in accordance to the Medical Products agency guideline and general advice on manufacture and importation of medicinal products (LVFS 2004:7)
• Strong organization skills with ability to organize, prioritize, manage multiple tasks and still keep focus on details
• Good interpersonal skills and team work spirit
• Analytical and results driven
• Broad pharmaceutical knowledge
• Excellent communication skills in Swedish and English (written and verbal communication)

Job Rewards and Benefits