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Healthcare QA Spec - QP/RP

Primary Location BUDAORS, BUDAORS, Hungary , 2040 Job ID R23021323

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Job Description:

Job Summary: This position is the Qualified Person/ Responsible Person role for Human and Animal Health secondary packaging activity and partly for the Wholesaler activity.

Monitors the overall Quality System status of the distribution center. This position acts in compliance to drug, medical device, and local regulations. Ensures quality processes are maintained through the implementation of procedures, training, and regular inspections.

Ensures the GMP compliance at GMP manufacturing site (Secondary Packaging) and GDP compliance at Wholesaler Activity.

Ensures all staff is trained in their respective job functions, including GMP/GDP.
Writes and revises Standard Operating Procedures as required.
Conducts regular inspections of the facility and recordkeeping, including summarization and reporting of findings. Coordinate or assist with corrective actions and preventative measures.
Communicates with clients and provides information during external audits
Liaises with Health Authorities during regulatory inspections.
Provides feedback and assistance to Customer/Client QA related questions and concerns.
Monitors the processes and systems within the Department to ensure regulatory compliance and effective operation.
Investigates discrepancies and problems, and advise the appropriate individuals of the findings.
Assists in development of pro-active strategies as a preemptive measure against potential future problems with systems or processes.
Completes NCR reports and change control requests and provide necessary follow-up.
Performs maintenance, support, and continuous improvements of Quality Systems.


Pharmaceutical, healthcare experience - Preferred
Quality Assurance experience - Preferred
Pharmacist degree is required

Employee Type:


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