Baxter
Healthcare
CountryQualityAssuranceOfficer(Błonie)
“Country Quality Assurance Officer (Błonie) at Baxter. Skills: Quality Assurance, Pharmaceutical Law, Quality Management System. Ensure compliance of operations with local processes. Ensure compliance with pharmaceutical legislation”
Industry & Context.
Problem solving; Analytical thinking
What They're Looking For.
Must Have
University degree in Scientific - Pharmacy, Valid right to practice pharmacist profession, At least 2 years of work experience in pharmaceutical wholesaler or pharmacy, Approval from Pharmacist Chamber, Very good English and native Polish, Ability to understand national rules and general regulatory and quality requirements
Nice to Have
Knowledge of Pharmaceutical Law, Knowledge of GDP, Knowledge of GMP, Knowledge of MDR, Knowledge of ISO 9001, Knowledge of ISO13485 regulations
What You'll Do.
Ensure compliance of operations with local processes
Ensure compliance with pharmaceutical legislation
Ensure compliance with Baxter's global procedures
Support Responsible Person
Perform functions of Responsible Person in absence
Develop local Quality Management System
Implement local Quality Management System
Oversee adherence to local Quality Management System
Ensure QMS compliance with Polish pharmaceutical legislation
Ensure QMS compliance with Baxter's global procedures
Support quality team in implementation of key quality
Support quality team in application of key quality
Manage risk management processes
Manage complaints processes
Manage hold and recall processes
Manage corrective and preventive actions
Manage change control process
Support audits by competent authorities
Support inspections by competent authorities
Support audits by notified bodies
Support inspections by notified bodies
Build relationships with Baxter group functions
Maintain relationships with Baxter group functions
How You'll Work.
Team & Collaboration
All functions of Baxter group
Communication Scope
Interpersonal skills
Process & Methodology
Project management
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