Baxter
Healthcare
CountryQualityAssuranceOfficer(Błonie)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“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
Full Job Description
**This is where** your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. **What will you be doing?** * Ensuring compliance of Baxter pharmaceutical wholesaler's operations with applicable local processes, pharmaceutical legislation and Baxter's global procedures. * Supporting the Responsible Person at the pharmaceutical wholesaler, performing the functions of the Responsible Person in his/her absence. * Developing, implementing, and overseeing adherence to the local Quality Management System (QMS) and ensuring its compliance with Polish pharmaceutical legislation and Baxter's global procedures (corporate QMS). * Supporting quality team in ensuring the implementation and application of key quality processes, including but not limited to: risk management, quality data analyzing, complaints, hold and recall processes, corrective and preventive actions (CAPA), deviations, change control process, preparation for audits and active support during audits/inspections carried out by competent authorities or notified bodies. * Building and maintaining good relationships with all functions of the Baxter group. **Your profile:** * University degree in Scientific - Pharmacy. * Valid the right to practice the pharmacist profession. * At least 2 years of work experience in a pharmaceutical
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