Resultados de la búsqueda: 21 vacantes
...Data Historian systems.
Support OT Systems lifecycle including validation activities by developing and executing qualification protocols plus associated documentation like System Functional and Design Specifications.
Perform scheduled OT Systems administration and...
...personnel on any technique they currently have in their training matrix.
Responsibilities
Proposes and implements scientific protocols to determine exception event cause.
Initiates appropriate exception documents in accordance with procedural requirements....
...Oral Solid Dosage and Parenteral Products.
GMP, FDA, EU regulations.
QA oversight manufacturing
Batch Record review and Protocol review
CAPA, Change Control and Annual Product Review
The Personality Part:
~ Being self-motivated means that you are...
...processes and procedures.
Develop Software/Computer Validation Protocols according to BMS policies on computerized systems validations.... ...software, as determined from the test performed on the protocol.
Analyzes data in order to determine acceptability. Recommends...
...looking for!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Designs, executes and evaluates method development protocols to ascertain the required degree of validation for new and existing methods guaranteeing implementation of a feasible, efficient,...
...time o part-time. Este puesto requiere trabajar continuamente con los jóvenes residentes, velar por su seguridad y siguiendo los protocolos internos establecidos, asegurando el bienestar de los menores mientras siguen la rutina de la institucion. Entre otras. Personas...
...providing scientific approach and Quality assurance direction to the approval of the GMP documents such as batch records, forms, protocols, procedures, qualification, and validation reports. Enforce critical analytical thinking in the investigation management process specifically...
...requiere trabajar continuamente con los jóvenes residentes en su diario vivir residencial, velar por su seguridad y siguiendo los protocolos internos establecidos. Entre otras.Requisitos:Personas interesadas deben tener: - Disponibilidad completa para turnos rotativos...
...time o part-time. Este puesto requiere trabajar continuamente con los jóvenes residentes, velar por su seguridad y siguiendo los protocolos internos establecidos. Entre otras.Requisitos:Personas interesadas deben tener: -Disponibilidad completa para turnos rotativos nocturnos...
...and English)
Project Management Skills
Experience in:
Parenteral Inspection and Packaging processes
Technical Writing (protocols, assessments, CAPAs, etc.)
Inspection/Packaging Technology experience (plus)
Project Management.
cGMP's, OSHA and FDA Regulations...
...years experience in method development/transfer of 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...
...and heating.
Working knowledge of boiler systems.
Proficient in balancing air and water treatment systems in line with HVAC protocols.
Excellent written, verbal and interpersonal skills.
Proficient in reading schematics and work plans.
Ability to work after...
...SOP’s, BR’s, BOM’s, WPP’s, URS, qualification and validation Protocols, validation plans according with government regulations and employer... ...approves the CSV Installation and Operational Qualification Protocol (IOQ) for computerized systems, and/or automated manufacturing...
...Analytical Method Validation Scientist
MAJOR DUTIES AND RESPONSIBILITIES:
#Designs, executes and evaluates method development protocols to ascertain the required degree of validation for new and existing methods guaranteeing implementation of a feasible, efficient,...
...Manufacturing operation facility
• Broad working experience with Change Controls/Change actions and CAPA
• Experience with validation protocols
• Strong technical writing and presentation skills
• Ability to interpret and analyze statistical data
• Knowledge in CGMP’s...
...take on this new challenge?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Knowledge with network communications protocol (i.e. TCP/IP)
Knowledge in Computerized System Validations.
Acquainted with GAMP5 methodology for validations.
Good skills...
...well as understanding of how they are applied to regulatory compliance.
~Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
~SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (...
...facilities and equipment qualifications in a manufacturing environment.
~Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
~SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (...
...well as understanding of how they are applied to regulatory compliance.
~Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
~SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (...
...support
~SOP Revisions
~Forms optimization project
~Change Control / Change Action Owner
~Support commissioning and validation deviations/protocols, originator, reviewer, and approver.
~New Equipment Data entry in Maximo (Computerized Maintenance Management System)...
