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Batch Management Analyst

Posted Date:  Nov 15, 2022
Requisition Number:  116141

Job Title                                                   Quality Analyst Batch Management

Reports to                                                Senior Quality supervisor

Department                                    Quality Control

Job Location                                  Guadalajara

 

Summary

 

Leading the interaction between production areas and supply materials to identify opportunities for improvement to assure the quality of the traceability and recall objectives using the tool of the batch management system. Performing periodical audits to verify the correct good receive and outcomes materials using a batch management system. All ingredients, including bulk material, not bulk material, in-process material/ WIP semi-finished goods, rework, stock feed, and waste products must be tracked from receiving through to finished goods and returns materials to the warehouse. Responsible for the inspection in-process and finished products, perform visual inspections, quality investigations of process related to quality issues as well as determining the proper process plans based on component specifications, perform inspection and analysis on incoming material, running tests, performing a variety of other quality inspection procedures. Utilizes a variety of inspection tools and improvises as needed to ensure parts and materials meet the drawing requirements. Helps determine methods and sequences necessary to inspect items. Works from diagrams, written and verbal description, layouts or defined plans to perform inspection and reviews rejected material, may determine disposition, and assist in corrective action plans. This is a new position needed in the Go life S4 project September 2022.

 

Responsibilities:

 

  • Coordinate & performing traceability audits to verify the compliance from a quality perspective.
  • Establishing improving with the production area, giving recommendations from the quality perspective to improve new processes: Reviewing and approving protocols and manuals
  • Coordinate tests: Managing HABL pulp inventories and raw materials validation
  • Posting waste & rework
  • Managing inventories waste & rework and making inventory adjustments by batch management.
  • Compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedure (SOP) by completing daily monitoring of the production lines using statistical analysis to determine correct sampling plan/frequency to insure valid inspection plans.
  • Completes accurate records (on paper and electronic data) to provide excellent results. Also completes accurate records for continuous improvement. These records include inspection
  • Reports, training records, equipment maintenance, continuous improvement initiatives, and corrective action reports. Understands the function and purpose of these records. Completes records neatly with a goal for 100% accuracy of content and spelling.
  • Release raw materials, in process and finished goods retain conduct by testing and analyzed in accordance with defined standard operating procedures on SAP.
  • Inspects and releases cleaning procedures related with allergens materials.
  • Write Non-Conforming Materials Reports when required and be familiar with the process of quarantining products that have been rejected.
  • Provide samples and communication to QA and Production Management concerning quality issues when required.
  • Once the opportunities for improvement have been detected with the person in charge will be responsible for leading the corrective actions in the different areas of the company to avoid recurrences.
  • Monitoring and verifying the correct batch management assigned through the system and use of the goods return material from production lines.
  • Promoting continuous improvement on the processes to reduce goods returns and having cost reductions.
  • Performing periodical audits to verify the correct goods receive.
  • Verify and monitor the manufacturing processes to document and assure its safety and quality.
  • Follow up the implemented corrective actions.

 

Minimum knowledge and skills

 

Specific Knowledge

  • Traceability and recall objectives using the tool of the batch management system.
  • Preference to certifications in precision inspection and other related disciplines.
  • Knowledge HACCP, GFSI,SQF
  • Experience with statistical plans and trending analyses.
  • Writing and speaking English skills. 80%

 

Skills

  • This position requires strong communication skills and the ability to interface with individuals at all levels and functions of the business.
  • Candidate should possesses a strong work ethic, a positive attitude, and be detail oriented Maintain the highest level of confidentiality.
  • Ability to adapt to a flexible schedule.
  • Proficient personal computer skills, including Microsoft Office

 

Education

 

This area work is open to all diplomats and graduates: Biology, Microbiology, Biochemistry, Chemistry or other relevant discipline.

 

Experience

 

Batch Managements process in experience in pharmaceutical processes

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