The QA Inspector will be responsible for sanitization, initial evaluations of complaints samples received in Aibonito, batch reviews requested for the complaints and complaints archiving. The incumbent must be knowledgeable of all manufacturing processes, product specifications, and quality functions and product usage (parenteral and/or medication delivery preferable).
Responsible for insuring compliance with the Quality System Regulation. Provide the Quality Associate, Quality Engineers / Supervisors with technical support for an effective samples evaluation. Responsible to ensure their responsibility areas are in compliance with internal and external regulations.
Perform and document routine inspections to production processes and Finished Products to ensure product compliance with all quality standards and specifications. Perform all product inspections and testing as required by company specifications in order to ensure product quality. Maintains update knowledge of all processes and product specifications. Perform data entry and data collection using Infinity QS data base system as applicable. Ensure that all machinery, equipment and tools used for testing comply with calibrations, company regulations, GMP and Federal Regulations.
Duties and Responsibilities:
1. Decontaminate samples as per required procedure.
2. Perform initial evaluations to the returned units as per individual specifications, BOM’s, blue print, etc.
3. Complaints area sanitization.
4. The QA Inspector will perform Batch Reviews for hospital complaints as requested by the product Surveillance Group.
5. Generate, archive and maintain all required documentation and reports in compliance with specifications, cGMP’s, current quality management system and any other regulatory requirements.
6. The QA Inspector will ensure that the complaints laboratory comply with all GMP, regulatory, corporate and internal requirements regarding house keeping, safety, etc.
7. Ensure that all machinery, equipment, tools or any other measuring, monitoring material complies with Corporate, GMP and other regulatory requirements.
8. Follow up quality engineers/supervisors on open complaints.
9. Keep in compliance with GMP, FDA, ISO requirements and other Regulatory Agencies.
10. Observe data privacy policies at all time.
11. Assist on the generation and investigation of non-conformities.
12. Responsible for conducting EHS inspections to identify and correct safety hazards and environmental aspects. Follow the EHS applicable procedures, and analyze EHS incidents (including near misses) to find causes and take corrective action.
13. Notify if is required generate Product Retention Records as applicable.
14. The QA Inspector will perform special test to Final Product as per specification and blue print applicable.
15. Generate the last disposition document to Final Product.
16. Prepare required documentation, Infinity QS entry, and summary reports of information collected as applicable.
Education and/or Experience:
High school graduate. Associate Degree Sciences or Business Administration preferred. A minimum of one years of medical knowledge or any related filed.
Job Type: Full-time
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