Description
Regional Quality Coordination Officer, for the region CIS & EuropeFor my client, an international Key Player in its area of Biopharma- Products, i am looking for a RQO ( Regional Quality Officer) - Specialist to support coordinate the international Quality Management for the regions CIS & Europe.
The specialist immediately required and will be assigned for a temporary limited contract (1 year+) based in Central Switzerland.
Regional Quality Coordination Officer (RQO)
Quality Management
- Manage Pharmaceutical Technical Complaint (PTC) handling and deviations in CIS Region
- Preparation of Quality Agreements & One Time Delivery Agreements (OTDAs) in CIS & Europe Region.
- Develop Quality procedural documentation in accordance with companys policies and procedures.
- Responsible for Elearning (E LearningAdministrator) for CIS Region
- Responsible for training of internal/external personnel in Quality relevant matters ( PTC handling, deviations etc.)
- Provide support to quality audits (e.g. Quality audits internal and external Vendor audits)
- Support Qualification of distributors
- Coordination of quality deviations in CIS & europe (participation in Quality deviation Meetings and discussions)
- Writing and reviewing quality SOP and working instructions
- Support new established affiliates, branches or rep. offices in quality matters
- Contribute to strategic company's projects as project manager or team member, as required.
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Coordinate the selection of qualified Quality staff at the distributor/agent. -
Ensure and organize that the appropriately reviewed and signed Quality Agreements and Confidential Agreements -
Facilitate mutual understanding and solution finding of country specific matters versus company global interests. -
Timely communication of upcoming audits and trainings. -
Reporting & Communication -
Consolidated written monthly report on key issues and progress. -
Active participation in team meetings, trainings and workshops
Requirements:
Minimum Master Degree in life-sciences (pharmacy, chemistry, biochemistry), PhD preferable.
- Fluency to negotiate in English and any additional languages are a plus.
- At least 4 years of professional working experience in Quality Management in a multinational innovative pharmaceutical company
- Knowledge in current European regulatory and GMP legislation's and guidelines
- Project management experience
- Understanding of regulatory & quality system
- Customer Focus: establishes and maintains effective relationships with distributors and gains their trust and respect and knowledge / understanding of the challenges in CIS markets.
- Planning and organizing: can orchestrate multiple activities at once to accomplish a goal.
- Problem solving: uses rigorous logic and methods to solve difficult problems with effective solutions
- Negotiation: Strong negotiation and communication skills.
- High communication skills
If you ave the feeling you could be a great fit for this position, please feel free to send me an updated version of your CV to...