Job Description
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Job Description
Job Summary:
This position 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.
Responsibilities
Ensures all staff is trained in their respective job functions, including GMP.
Writes and revises Standard Operating Procedures as required.
Reviews and approves operational WIs.
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 TFDA officials during regulatory audits.
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.
Approves NCR reports and change control requests and provide necessary follow-up.
Performs maintenance, support, and continuous improvements of Quality Systems.
RP designation duties.
Qualifications
Pharmaceutical, medical device, healthcare or food industry experience - Preferred
Quality Assurance Experience - Preferred
Bachelor's Degree in Science related field (or internationally comparable degree) required - Preferred
Employee Type
Permanent
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