QA Specialist ESO

Be a part of the winning culture!

What Would Be Your Main Responsibilities

Operational quality management of a dedicated product portfolio

• Quality management of deviation and complaint records and their related CAPAs
• Assessment and management of change controls
• Edition of QA Agreements with Zentiva third parties and subcontractors
• Collection and evaluation of PQRs and stability data
• Compliance evaluation of Third Parties and products
• Maintenance of product database
• Collection and review of CoA/CoC
• QA support of product launches and transfers
  

GMP, GDP, MDR, HACCP, Food Supplements and Cosmetics regulations and legislations.

Auditing

• Prepare audit and audit plans
• Conduct and participate to external audits
• Evaluation of audit reports
• Participate to internal audits and inspections
  

KPI monitoring and reporting

We Need You To Have

• University degree in Pharmacy, Chemistry, Biology, or relevant Life Science
• Minimum of 5 years in a similar role or equivalent experiences in a GMP related environment.
• Thorough knowledge of GMP requirements as well as knowledge of ICH and pharmaceutical regulatory requirements.
• Experience in management of subcontractors is an advantage.
• Proven track record of project management skills.
• Strong communication and negotiation skills.
• Proactive attitude, problem solving skills, hands-on attitude, flexible and open minded personality.
• Collaborative and team-spirited.
• Knowledge of IT tools
• Language - English: Advanced level
  

It is crucial for us to have satisfied employees. Therefore, we can offer you the following:

• Competitive salary;
• Additional benefit package;
• Hybrid mode of work;
• International working environment and a passionate team of professionals;
• Continuous Learning & Development opportunities.