Resultados de la búsqueda: 23 vacantes
...required to carry out.
Monitors operator training files and works with compliance specialist to keep files up to date.
Works with QA and Subject Matter Experts (Tech Ops or Process Sciences) to resolve exceptions.
Works with technology transfer team to...
...Engineer or formal training in quality engineering or statistics is preferred
~15+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical, biologics, device or chemical industry
~ Must have a basic understanding and working knowledge of the physical...
...immediacy of supervision:
• Working relationship with unit’s members and unit Teams from other disciplines (Engineering/Maintenance, MS&T, QA/QC, LOSM, SC, etc.). Also works with minimum supervision, with periodic monitoring and review of results.
CONTACTS Describe the...
...to ensure proper utilization of MES and EBR systems and adherence to established procedures.
Collaborate with Quality Assurance (QA) and Regulatory Affairs teams to ensure compliance with relevant regulatory guidelines, such as FDA 21 CFR Part 11.
Implement data...
...CAPAs. A minimum of three (3) years of experience managing direct reports.
Experience in pharmaceutical/biotechnology operations , QA or technical support is necessary to successfully perform responsibilities of the position.
Advanced technical writing skills...
...Policies.
#Provides support to the area QA Leader during the budget preparation activities... ...level criteria when additional or special testing is required.
#Performs trend analysis to... ..., inconsistencies and interpret sampling test results
~Proficient knowledge of problem...
...Monitoring clean utilities
~ Monitoring to freezers
~Monitoring, operation and repair of drinking water system
~ Water chemistry tests
~Execute preventive maintenance, troubleshooting and general repair work on specific assigned working area/site of mechanical,...
...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...
...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...
...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).
~Experience with Refrigerator/Freezers operations / qualifications, data loggers and Kaye validator...
