Healthcare QA Specialist

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Job Description:

This is a fixed-term role (1 year), with working hours from 8:00 to 17:00. The position is site-based, with no remote work option.

Job Summary

This position monitors the overall Quality System status of the distribution center. This position acts in compliance to ISO 9001 and ISO 13485 standards and in compliance with the EU GMP and EU GDP Guidelines.

Responsibilities:

• Ensures all staff is trained in their respective job functions, including GMP.

• 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 internal, client or regulatory agency auditor.

• Initiates, investigates and assesses non-conformances.

• Develops corrective action plans in co-ordination with facility management and applicable subject matter experts (SME).

• 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. Supports with initiation and documentation of Change Controls and tracks them to closure.

• Assists in development of pro-active strategies as a preemptive measure against potential future problems with systems or processes.

• Supports with investigation of non-conformance and customer complaints

• Collects and assesses quality management system metrics

• Tracks site employee training.

Qualifications:

• Experience and Knowledge in GMP and/or GDP guidelines - Required

• Experience with ISO 13485 and ISO 9001 standards - Required

• Proficiency in English required (written & verbal)

• Strong communication skills

• Advanced knowledge of Microsoft O365 (Excel, Word, Outlook, Access).​

• Proven working experience in a highly regulated Distribution/Manufacturing environment. 

• Proficiency in warehouse management and quality management systems

• Able to work within time-limits (deadlines), persistent​​

• Ability to work with different electronic systems

Employee Type:
 

Fixed Term (Fixed Term)

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