Quality Control Manager - FDA
Quality Control Manager - FDA
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Job Description
Are you an experienced quality professional ready to take on a leadership role in one of Mexicos most recognized pharmaceutical companies
In this position youll lead a team of inspectors manage FDA compliance and ensure seamless adherence to Good Storage and Distribution Practices. Your daytoday will include reviewing product inspections overseeing audits maintaining quality systems and working directly with suppliers and health authorities to uphold the highest standards of product integrity.
Job Description
The Quality Control Manager is a critical part in safeguarding the quality and integrity of stored and distributed medical supplies ensuring compliance with health regulations and contributing to customer satisfaction.
Key Responsibilities
Oversee the assessment of incoming products through physical inspection and review of analytical certificates (when applicable) ensuring they meet established quality standards.
Delegate product inspection tasks to Quality Control Inspectors based on workload and operational needs ensuring timely system updates (approval/rejection) and product availability for order fulfillment.
Review and approve inspection reports submitted by inspectors validating data accuracy by comparing system entries with physical documentation.
Monitor the performance of quality control personnel ensuring adherence to assigned duties and internal company policies.
Initiate corrective action requests for quality deviations detected during inspections notify suppliers and ensure resolution through proper followup.
Manage and resolve productrelated customer complaints via the corporate portal promoting a culture of continuous improvement.
Oversee the handling of product returns from pharmacies due to quality issues in accordance with established procedures and determine final disposition (supplier return or destruction).
Prepare and analyze monthly inspection reports using data from inspection logs and internal systems to evaluate supplier quality performance.
Required Experience
Associate degree in Pharmaceutical or Chemistry field.
2 to 3 years of experience as a Health Manager or similar role in pharmaceutical distribution or warehousing.
Proven expertise in FDA compliance and related regulatory standards for pharmaceutical storage and distribution.
Experience in implementing and maintaining Quality Management Systems.
Familiarity with pharmaceutical manufacturing quality processes.
Technical Skills
Indepth knowledge of FDA compliance and related pharmaceutical regulations.
Proficiency in Quality Management Systems and Continuous Improvement methodologies.
Strong understanding of Good Storage and Distribution Practices (GSDP).
Document control proficiency including SOP (PNO) management.
Proficiency in Microsoft Office and related software tools.
Please email your resume to to apply directly.
Required Experience:
Manager
Employment Type
Full Time
