...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...
...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...
...equipment upgrades, replacements, and modifications in the manufacturing / production area.
• Develops and executes validation protocols and reporting.
• Applies advanced and diverse validation engineering principles to the design and implementation of major systems...
...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...
...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...
...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,...
...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...
...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...
...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...
...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 (...
...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)...
...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 (...
...in providing training on scientific or technical aspects of the processes.
~Assists with generation and execution of validation protocols and reports.
~Participates in regulatory inspections when necessary.
~Assists the area managers and supervisory personnel to solve...
...applied to regulatory compliance.
~Experience with Facilities Qualifications, Risk Assessments, Traceability Matrix and IQ, OQ, PQ protocols development and execution, deviations and reports generation
~Technical Writing skills and investigations processes.
~Available...
...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...
...then bring it on!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Prepare validation or performance qualification protocols for manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products.
Develop...
...related to equipment performance.
Support the periodic review of equipment/system qualifications studies.
Generate & execute protocols; IQ, OQ, PQ Generate and execute equipment/software validation protocols (IQ, TMV, TQF, Process Characterization and Process...
...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....
...projects mostly through lab and/or site activities where applicable.
• Contribute to writing and conceptual framework of technical protocols, reports, publications and presentations. Conveys information effectively through verbal, written, and presentations to...
...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...
...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...