Senior QA/RA Specialist Sweden 6 month Contract
One of the largest Pharmaceutical Company is offering a fantastic opportunity for an experienced Senior Quality Assurance Regulatory Affairs Specialist to join a dynamic team based in Sweden who will be reporting to the Manager QA/RA, Global Affiliates.
Key Responsibilities:
As a Senior QA/RA Specialist you will provide Quality Assurance support to the Specialist Pharmaceutical organisations to ensure that the products are distributed in accordance with their marketing authorisations, and that the principles and guidelines of current Good Manufacturing Practices (GMP), Good Wholesaling Practices (GWP) and Good Distribution Practices (GDP) are compiled respectively at Affiliate office and supporting suppliers.
*Maintenance and development of Nordic Quality Management Systems (QMS)
*Market release of products
*Managing quality related complaints
*Managing deviations
*Maintain required license in the region
*Report controlled drug transactions to the Health authorities on yearly and quarterly basis
*Training of personnel on GDP
*Perform GDP audits on suppliers in Nordic region
*Support local Health authorities inspections and internal audits
*Provide Quality Assurance support for local affiliate product launches including controlled drugs
*Review and approve artworks for packaging materials labelling changes as requested by Global QA & RA
*Review promotional and non-promotional materials ensuring compliance with applicable law
The successful Senior QA/RA Specialist ideally will have:
*University degree or equivalent qualification in a Scientific discipline
*Minimum 2-3 years Practical experience in the Pharmaceutical industry ideally in manufacturing / technical / QA or QC role(s)
*Good working knowledge of EU GMPs, GDPs
*Fluent in English
*Strong technical / QA background to enable working with contractors and in isolation
*Ability to deal with problems arising, develop and maintain good relationships with third parties
*Logical problem solver
*Excellent communicator and team player
*Ability to influence positively without direct authority
The company will provide an opportunity to progress your career as a Senior QA/RA Specialist where you can further develop your skill set. The contract offered may potentially be extended.
For further information on the role or company please contact myself, Clare Selfe at Paramount Recruitment on 0121 616 3466.
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