RQO Poland Responsible Person

Purpose:

The purpose of the Regional Quality Officer (RQO) role is to act as the GDP Responsible Person for Poland and to operate Quality system in the territory (including Czech Republic, Slovakia and Hungary) responsibility in full compliance and to represent CSL Behring (CSLB) Quality in the assigned affiliates/branch office or distributor markets as well as towards CSL Behring manufacturing sites QA and CSL Global Quality

QA (Quality Assurance) Support - QA activities & Management

• Implements and maintains the Quality Management System (QMS) in compliance with all regulations (international, local) and Global CSL Behring standards in the assigned affiliates/branch offices or distributor markets
  
• The quality activities include but are not limited to batch release, change control, complaints, and deviation management.
  
• Provides 3PLs/distributors vendor oversight, and supports qualification, selection, and negotiation of new suppliers.
  
• Supports new product launches and ensures compliance of the existing lifecycle products.

• Participates in the local Commercial Operations Leadership Team meetings, periodic business review meetings and provides input to strategic planning and discussions.
  
• Primary point of contact to and from Global or Regional Quality, ensuring a timely, two-way communication above country and in market.
  
• Collaborates with other affiliates and Global Quality group to benchmark best quality practices to mature quality culture for the affiliate the RQO is responsible for.
  

• Deviation Management
  
• Corrective Action & Preventive Action (CAPA) Management
  
• Product Complaints Management
  
• Change Control Management,
  
• Documentation Management
  
• Training Management
  
• Recall Management
  
• Self-Inspection Management
  
• Quality Risk Management
  

• Degree in pharmacy or life science (if required by local legislation) or equivalent experience
  
• At least 5-7 years of experience in the pharmaceutical industry, of which 4 years of experience in Quality Management Systems and in warehouse management.
  
• Fluent in local language in the assigned affiliates/branch office or distributor markets and good knowledge of oral and written English.
  
• Understands and has experience in pharmaceutical quality assurance systems.
  
• Knowledge of Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), and local regulations and guidelines as applicable to the level of activities carried out at the affiliate or region.