...providing technical expertise and support by designing and executing validation activities required to comply with domestic and international quality standards within our global... ...manufacturing environment.
~Knowledge in validation design, testing and development of statistic....
...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...
...to assure compliance according to the appropriate federal and international regulations which govern the user's applications. Reports on the... ...of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using...
...procedures, and programs to ensure compliance with local and international regulations.
~ Interface with, Federal, State & Local Agencies... ...are in place and up-to-date.
~ Provide input into the design and construction of the solar PV plant to ensure that HSE considerations...
...AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Designs and plans layout for activities such as machining, metal forming... ...assembly, and materials handling.
Adapts machine or equipment design to factory and production conditions.
Designs arrangement of...
...Developing and managing GMP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance testing, traceability matrix, system, Validation Reports, SOPs,...
...manufacturing industry in Puerto Rico & USA.
Responsibilities:
Designs manufacturing processes, procedures and production layouts for... ...and material handling.
Adapts machine or equipment design to factory and production conditions.
Inspects performance of...
...maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
Reports on the status of validation activities to fulfill regulatory...
...support to Chemical Laboratory personnel in any associated activity. Follow current procedures and ensure compliance with corporate internal policies and external regulations (safety and 6S guidelines included).Requisitos:• EDUCATION and/or EXPERIENCE Bachelor's Degree (...
...technology
~ Ability to document within available EMR.
~ Experience in any of the following medical specialties:
~ Geriatrics
~ Internal Medicine
~ Primary Care
Why EasyHealth?
Join an organization that values boldness, ambition, collaboration, and a...
...situations, to solve quality issues, to improve process, or to confirm reliability of products.
Collaborates with technical experts, design team, and other facilities for the process development of new devices.
Supports process owners.
Works on complex problems...
...Validation, Equipment IQ and Computer software validation.
Designs manufacturing processes, procedures and production layouts for... ...that affect product performance.
Adapts machine or equipment design to factory and production conditions.
May incorporate inspection...
...support to Chemical Laboratory personnel in any associated activity.
Follow current procedures and ensure compliance with corporate internal policies and external regulations (safety and 6S guidelines included).
Fills the corresponding “Out of Service” Tag, as...
...tools (e.g., RSMeans, Bluebeam).
~Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal teams and external stakeholders.
~Detail-oriented and organized, with the ability to manage multiple projects and deadlines.
~...
...compliance.
Ensure the necessary spare parts and require tools for the maintenance tasks.
Ensure the total completion of the designed maintenance plan.
Perform other duties as assigned.
REQUIREMENTS:
Refrigeration Licence
Minimum of 7 years of...
...precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment;... ...compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and...
....
~ Imagination, Interpersonal, Problem-solving, Analytical/critical, Reading and Writing skills
~ D ata-centered mentality. Ability to design and implement processes to solve challenges based on data.
~ Fluency in English and Spanish is required...