...&S management system requirements and compliance obligations, promote continuous improvement, and consider EH&S aspects during the design and change process.
Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal...
...validation activities by developing and executing qualification protocols plus associated documentation like System Functional and Design Specifications.
Perform scheduled OT Systems administration and maintenance tasks such as operating systems (OS) and anti-virus...
...Independently design, execute and interpret critical experiments to answer scientific questions for manufacturing technical evaluation, new product introduction, or continuous process improvement initiatives. To apply visit our site or send your resume to ******:Bachelor...
...affinity diagrams, brainstorming, etc.). Applies critical thinking to discern relevant information to the investigation report.
Design CAPAs aligned to root cause that are effective in preventing recurrences. Assign CA-PA with reasonable timeframes, track due dates,...
...Imprimir toda la documentación necesaria para la aceptación y firma por parte del cliente.
Cotizar con la compañía de seguros designada el valor de la póliza a incluir en cada negocio.
Entrar toda la información necesaria en el “DMS” para propósitos de facturación...
...orden de pieza.
#Es responsable de hacer buen uso de las herramientas suplidas por la empresa, esto incluye devolverlas a su área designada e informar a su supervisor de algún problema con la referida herramienta.
# Debe poseer un inventario saludable de herramientas...
...Five (5) years of experience in computerized system validation of pharmaceutical or biopharmaceutical industry.
Experience in:
Design and execution of compliant and efficient validation strategies for system and equipment supporting the Manatí Site.
Development...
...in method development/transfer of biomolecules.
#Experience designing, executing and evaluating method development protocols for new... ...dosage forms.
#Knowledge of Statistical Process Control, and Design of Experiments with demonstrated analytical and problem-solving...
...equipment can handle all current products configuration components and will determine whether it can support proposed changes.
Justify, design, specify, purchase, test, install and validate any new equipment purchases.
Manage project timetables for new and ongoing...
...support proposed changes in packaging components.
Support, assist and /or justify packaging capital projects help research, such as designs, specifies, purchases, tests, installs, and validates any new equipment purchases
BEING A FITS PIECE COMES WITH PERKS:
~ One...
...even to the environment, you might just be what we’re 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...
...Develops and executes validation protocols and reporting.
• Applies advanced and diverse validation engineering principles to the design and implementation of major systems or process modifications.
• Completes complex or Client assignments requiring development of...
...process and analytical and microbiology laboratory.
Review/Approve equipment/facilities/system validation documents such as Users design Specifications (URS), Design Specifications(DQ), Risk Assessment(RA), Data Mapping/Data Flow/data Integrity, Audit Trail Review...
...proposed changes.
#Supports, assists and /or justifies inspection technology/operations capital projects help research.
#Justifies, designs, specifies, purchases, tests, installs and validates any new equipment purchases.
#Plans, coordinates, and executes projects to...
...knowledge in cGxP and regulatory guidance as 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...
...Engineering.
~Experience in pharmaceutical 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...
...overall experience and 2 years on parenteral manufacturing environment experience years in parenteral products forms.
~Proficient in design and execution of Cleaning Qualification studies.
~Technical knowledge in pharmaceutical manufacturing processes/technologies and...
...knowledge in cGxP and regulatory guidance as 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...
...there are effective systems for the maintenance and calibration of equipments and approves of calibration requests.
#Ensures the designation and monitoring of storage conditions for quarantine materials and products.
#Reviews and approves procedures related to process,...