...performed in aseptic or non-aseptic environments. Perform process tests and participate in qualification and validation activities as... ...systems.
Strict adherence to current Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP) and accurately complete...
...America.
Responsibilities:
~ Ability to assemble, install, test and maintain electrical or electronic wiring, equipment,... ...Ensure that all documents are completed complying with the GMP’s practices when required.
~ Provide cover for other members of staff during...
...manufacturing operation continuance issues and process improvements.
Perform or review configuration and programming using defined practices to establish compliance with users and functional requirements.
Provides training for OT Systems Users/Engineers in new...
...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...
...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 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...
...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...
...that supports the identified root cause or most probable cause.
Train investigators and cross functional team members on the best practices to write investigation reports that are factual, clear, coherent, concise, complete, compliant.
Apply 6-sigma principles to the...
...inspections to ensure compliance with regulatory agencies, company environmental, health, and safety policies, quality procedures and practices.
~ Maintain internal and regulatory reporting including data collection and reporting including but not limited to air, storm...
...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...
...de conformidad con GAAP.
# Evalúa y realiza los ajustes apropiados en los procesos de contabilidad interna, asegurando que las prácticas estén en línea con los objetivos generales de la organización y GAAP.
# Asiste al Gerente de Contabilidad en la preparación de...
...regulations and the current Good Manufacturing Practices required by the job function.
MAJOR... ...criteria when additional or special testing is required.
#Performs trend analysis to... ..., inconsistencies and interpret sampling test results
~Proficient knowledge of problem...
...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...
...and the ability to juggle multiple projects simultaneously.
Understanding of communications, public relations and marketing best practices including social media channels
Must possess exceptional writing skills and be able to compose engaging and accurate content....
...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...
...focusing on recognizing, evaluating, and controlling environmental hazards.
~ Advice management on the proper procedures, work practices, equipment to use in order to ensure compliance with all legal requirement and regulations in these fields.
~ Implements EHS self...
...:
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...
...tiempo, de manera que son asignados.
Entregas & Pickups: Manejo de los vehículos y su mantenimiento; siguiendo las políticas y prácticas de la compañía en referencia al manejo seguro, y siguiendo las leyes locales y estatales para una operación segura de un vehículo....
...Spanish)
Administrative and according to business needs
Experience in:
system validation, qualification, and documentation practices in a regulated environment.
MES and EBR software platforms such as Werum PAS-X, Rockwell Automation PharmaSuite, Emerson...
...who drives execution excellence through the People Services (PS) team.Leverages business strategy, people strategy, external best-practices and organizational insights to deliver bold and innovative organizational and talent solutions.Leads and drives the talent plan with...
...Incumbent must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
1. Leads all product batch records efforts to collect and monitor information for new and existing...
...coordinate document reviews and approvals.
~Assist in the development and implementation of document control procedures and best practices.
~Provide training and support to employees on document control processes and systems.
~Conduct periodic audits of document control...
...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...
...environment.
Attention to detail and a commitment to maintaining high standards of quality and compliance in laboratory asset management practices.
Physical Requirements and Working Environment:
While performing the duties of this job, the employee is regularly required...
...#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...