Resultados de la búsqueda: 19 vacantes
...and data mappings for new systems aligned with site Data Integrity master Plan and applicable processes and procedures.
Develop test scripts to confirm the computerized systems are in compliance with data integrity requirement, User and Design Specification requirements...
...markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
Analyze test results, machine error messages, and information obtained in order to diagnose equipment problems.
Clean, lubricate, and adjust...
...existing methods guaranteeing implementation of a feasible, efficient, rugged, and robust method.
Supports technical aspects of test method ruggedness and robustness processes.
Supports the Analytical Ruggedness Project Manager and Quality Control to gather information...
...commitments over this horizon. Details of activities include key NPI launches, projects that support overall plant efficiency improvements, test method transfers , and future strategy and vision development.
Responsibilities
Lead all aspects of NPI projects from...
...Improve inspection processes, technologies, and systems to ensure compliance with drug quality and cost specifications.
Write test procedures, inspection machinery specifications, performs line trials and troubleshooting, work with inspection technology machinery...
...procedural requirements and scientific principles. Performs laboratory testing within a GMP environment in support of one or more of the... ...changes to maintain procedural requirements.
Performs analytical test methods as written to support product/material release with...
...job)
Improve packaging processes, technologies and systems to insure compliance with drug quality and cost specifications.
Write test procedures, packaging machinery specifications, performs line trials and troubleshooting, works with packaging machinery vendors,...
...biomolecules.
#Experience designing, executing and evaluating method development protocols for new and existing methods.
#Proficient in test method and processes.
#Technical knowledge with experience in biomolecules method optimization and troubleshooting.
#Broad...
...:
E xperience related to a Laboratory equipment qualification documents development, execution and report as well as laboratory test method creation and configuration in the applicable instrument software.
Regulations (Risk Assessment, Data Mapping etc.), EU regulations...
...be readily available.
~ Determine need for upgrading HVAC systems and take measures to take necessary actions
~ Reassemble and test equipment following repairs.
~ Record and report all faults, deficiencies, and other unusual occurrences, as well as the time and...
...Job Description
Purpose
Manages the resources to assures completion and approval of testing of raw materials, in process and final product samples tested in the Microbiology Laboratory in a timely manner yet assuring the corporation that required tests are...
...in the manufacturing area to confirm operational status. Work is performed in aseptic or non-aseptic environments. Perform process tests and participate in qualification and validation activities as required.
Responsibilities
Inspect manufacturing equipment to monitor...
...Validation Plan and Reports, DCS, QBASM and QBAS Design Specification and Qualification Documents, among others.
Reviews/approve test script and manage revision/approval of the deviation investigation process ( initial phase, execution, final phase/approval) in the...
...#Improves inspection processes, technologies and systems to ensure compliance with drug quality and cost specifications.
#Writes test procedures, inspection machinery specifications, performs line trials and troubleshooting, works with inspection technology machinery...
...protocols development and execution, deviations and reports generation.
~SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
~Strong knowledge (according to related area).
~Technical Writing skills and investigations processes...
...Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
~ Ability to assemble, install, test and maintain electrical or electronic wiring, equipment, appliances,
~Maintain electrical equipment to meet regulatory codes at state...
...protocols development and execution, deviations and reports generation.
~SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
~Experience with Refrigerator/Freezers operations / qualifications, data loggers and Kaye validator...
...protocols development and execution, deviations and reports generation.
~SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
~Strong knowledge (according to related area).
~Technical Writing skills and investigations processes...
...on acceptance quality level criteria when additional or special testing is required.
#Performs trend analysis to provide recommendations... ...detecting deviations, inconsistencies and interpret sampling test results
~Proficient knowledge of problem solving and root cause...
