...talented, dedicated individual committed to work under the highest ethics standards for the following position:
~ Commissioning / Qualification Specialist
Qualifications:
~Bachelor's Degree in Science or Engineering.
~Experience in pharmaceutical facilities and...
...individual committed to work under the highest ethics standards for the following position:
~Computer System Validation (CSV) / Qualification Scientist
Qualifications:
~Bachelor's Degree in Science or Engineering.
~Minimum of 5 years of experience in direct...
...Mexico, Germany, Canada, and South America.
Responsibilities:
Review contractor's Job Hazard Analisys.
Review contractor's qualification documents
Inform any deviation on SOP’s from Project Engineering and EHS Departments. Support in the implementation of health...
...procedures are in compliance with regulations.
Work on the introduction on a new product.
Change control of Medical Devices
Qualifications:
Bachelor Degree in Engineering
Three (3) or more years of experience
Experience in equipment IQ
Experience in OQ (...
...AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Conduct process equipment installation/operational/performance qualification studies to test their functionality.
Prepare operational qualification assessments to support that validated critical operating...
...Validation Specialist with experience in regulated industry, validating/qualifying laboratory equipment, manufacturing equipment, processes... ...complete validation cycle
Change Control
Equipment qualification (manufacturing and laboratory)
Requirements
Bachelor in...
...website qrcgroup.com / to learn more about our services and solutions!
Job Description
Validation Specialist to provide support to qualification and validation activities related to manufacturing equipment. This resource will attend all related meetings, making...
...concepts.
Advises the IT Computerized System Validation manager (or designee) on the adequacy/completeness of Software Operational Qualification Protocols for his/her approval.
Provides technical counsel on issues and concerns regarding validation plans and protocols...
...talented, dedicated individual committed to work under the highest ethics standards for the following position:
~C&Q Specialist for Multiple Facility Qualifications and Utilities
~Various GMP Suites
~Support Areas
~HVAC, Chilled Water, Reheat Water, Compressed Air, Steam...
...Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational... ...packaging, inspection, and new products
• Validated experience in Commissioning and Qualification
• Strong organizational skills,...
...NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
Qualifications:
~ Bachelor's degree in Life Science and/or Engineering.
~5 years of directly related experience
~ Able to Perform Trackwise...
...Investigations Specialist with experience in regulated industries. Strong knowledge of complaints and processes deviations. Will be responsible for performing through, detailed and timely investigations and generation of high quality and timely investigation reports...
...organizing data and preparing appropriate documentation for assigned projects.
Collect data and technical reports/ assessments.
Qualifications:
Bachelors Degree in Engineering or Science
Two (2) or three (3) years of previous experience
Must have experience in...
...Industry (Parenteral Manufacturing/Packaging Operations) or Medical Device.Strong background on equipment/facility/computer system qualification, validation.Excellent technical writing/oral communication skills (English/Spanish).Availability to work non-standard shifts,...
...CSV Specialist for laboratory equipment.
Skills:
Laboratory instruments qualification
Validation Cycle
Requirements
Bachelor Degree in Science
At least 5 years of experience in related area
Biligual (Spanish/English)
Technical Writing...
Minimum Requirements
Mid-level individual contributor on a project or work team, 3-5 years of experience required.
Bachelor Degree in Engineering
Experience within Medical Devices and/or Pharmaceutical industries.
Experience in equipment IQ, OQ and PQ, Validation...
...availability of current techniques.
Performs system administration and configuration of quality information technology systems.
Qualifications:
Bachelor's degree in Engineering or Science
Four (4) or more years of relevant experience
Investigation and root...
...environmental self-inspection and environmental compliance self-inspection include Carolina, Punta Salinas and Aguadilla sites.
Qualifications Requirements/Knowledge/Education/Skills:
~ Bachelor Degree
Mentor Technical Group es un empleador que ofrece igualdad...
For Quality services in the Drug Substance area
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor’s Degree with five (5) years of directly experience as Quality Professional in the regulated industry.
Bilingual (English & Spanish)
Project Management skills...
...framework for measuring and improving our performance. Compliance Specialist 2018 2 Job Description GIDEP).
Act as a point of contact... ...supervisor) to support normal client site operations.
Qualifications Requirements/Knowledge/Education/Skills:
~ Bachelor's degree...
For Documentation Support services.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor’s Degree with 3-5 of experience in document control within the Pharmaceutical or Medical Device industry.
Bilingual, Spanish and English
Shift: Administrative and according...
...The Validation Specialist I should have experience in validation life cycle and will also c ontribute intermediate to advanced level... ...solve equipment malfunctions.
# Execute change requests and qualifications for existing equipment. Provide support to PTO in validations...
...established by our customers, in order to perform and provide a highly effective service.
Validation Engineer/Specialist is required to support Validation/Qualification activities in a Medical Devices manufacturing environment.
Minimum Requirements:
Bachelor Degree in...
...assigned training to permit execution of required tasks • Performs additional duties as specified by management
PREFERRED QUALIFICATION • Project management skills • Strong organizational skills, including ability to follow assignments through to completion •...
...applicants in travel arrangements.
Perform Quality Assurance Checks on all applicant files.
Other duties as assigned.
Qualifications
Requirements: To perform this job successfully, an individual must be able to perform each essential duty...
...Germany, Canada, and South America.
Responsibilities:
~Commissioning Forms
~C/Q/V Protocols and Summary Reports
~Standard Operating... ...Impact/Risk Assessments Specifications (URS/FRS/DS).
Qualifications Requirements/Knowledge/Education/Skills:
~ BS / BA in...
For Sterilization and Validation support services in the Laboratory area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor’s degree in Natural Science (Biology or Microbiology preferred) and previous exposure of Sterilization Validation activities within the...
...1. Participate on the assessment or implementation of special projects or initiatives.
** Other functions may be assigned. QUALIFICATIONS / REQUIREMENTS NEEDED
Perform Trackwise system queries, deviations
• Participate in triage process
• Perform oversight of...
.../ GED and 12 years of directly related experience.
Educational background in Life Science and/or Engineering.
Preferred Qualifications:
• Perform Trackwise system queries, deviations
• Participate in triage process
• Perform oversight of the process and procedures...
...dedicated individual committed to work under the highest ethics standards for the following position:
~Documentation Specialist for GMP Industry
Qualifications:
The Documentation Specialist will work with the Document Control Group Leader to achieve an efficient...