ESO QA Specialist

Job Description:

Responsibilities

• 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

Qualification & Expeirence

• 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
• Management of subcontractors is an advantage
• Proven track record of project management skills
• Strong communication skills and negotiation strength