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Lab Systems Validation Specialist job

PRA Health Sciences jobs

Company

Skills

Company Description

The story of PRA Health Sciences would naturally talk about how we’ve become one of the world’s largest CROs. It would talk about our innovation and growth and would speak to our operational efficiencies and transparency. It would highlight our expertise and customization. And it would touch on the incredible differences we’ve made, over our more than 30 years, in helping to bring to market everything from niche treatments and therapies to blockbuster drugs. More than anything else, our story would be about people. Not only our over 15,000 employees operating in more than 85 countries, though they’d certainly be a big part of it, but also the people that inspire them. The heroes of any PRA Health Sciences story are the clients we serve and the people whose lives we help improve, all over the world. And our story has only just begun.

Job Description

Overview


Do you want to watch clinical development change, or do you want to be the one to shape it?

Because were hoping youre here for the latter.Who are we?We Are PRA Bioanalytical Labs, with locations in Lenexa, KS USA and Assen, Netherlands, EU.We are part of the 16,000+ employees strong for PRA Health Sciences, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.

Responsibilities


Responsible for initiation, organization and review of all necessary (periodic) validation activities, in order to secure GxP compliance of all equipment and systems used.
  • Assist in preparing Validation Files.
  • Executing and reporting Periodic Review
  • Assist in writing, reviewing and finalizing Validation Documentation.
  • Performing tests as described in the Validation Plan.
  • Evaluating already validated systems.
  • Assist tracking information about validations in system inventory.
  • Assist in improvement projects/corrective and preventive actions.
  • Participating in the continuous improvement of processes and quality.
  • Assist in (re)writing SOPs, Work Instruction and reference documents.
  • Identifying and reporting quality issues regarding applications and systems.
  • Support the System Owners when performing validation projects or act as a project leader within a validation team.
  • Inform System Owner when validation project should be carried out.
  • Advising a System Owner about the steps he should take.
  • Executing and reporting Periodic Review
  • Create a Validation File.
  • Create a Validation Plan.
  • Coordinating, co-writing, reviewing and releasing Validation Documentation.
  • Transferring knowledge of validation within the site.
  • Tracking information about validations in system inventory.
  • Providing support in (re)writing SOPs, Work Instruction and reference documents.
  • Advising on corrective and preventive actions.
  • Participating in improvement projects/corrective and preventive actions.
Qualifications
  • Bachelor degree in relevant field
  • 1-4 years relevant experience
  • Knowledge of GxP, GAMP & FDA guidelines and 21 CFR Part 11.
  • Knowledge of lab or clinic applications.
  • Read, write, and speak fluent English; fluent in host country language required
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

TASKS

  • Conduct chemical analysis of body fluids, including blood, urine, or spinal fluid, to determine presence of normal or abnormal components.
  • Analyze laboratory findings to check the accuracy of the results.
  • Operate, calibrate, or maintain equipment used in quantitative or qualitative analysis, such as spectrophotometers, calorimeters, flame photometers, or computer-controlled analyzers.
  • Collect and study blood samples to determine the number of cells, their morphology, or their blood group, blood type, or compatibility for transfusion purposes, using microscopic techniques.

SKILLS

  • Reading ComprehensionUnderstanding written sentences and paragraphs in work related documents.
  • Active ListeningGiving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
  • WritingCommunicating effectively in writing as appropriate for the needs of the audience.
  • SpeakingTalking to others to convey information effectively.

KNOWLEDGE

  • ClericalKnowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
  • Customer and Personal ServiceKnowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
  • MechanicalKnowledge of machines and tools, including their designs, uses, repair, and maintenance.
  • MathematicsKnowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.

PRA Health Sciences

Type

Company - Public

Size

10000+

Revenue

$100M to $500M

Location

Raleigh, NC,

Industry

Pharmaceutical/Bio-tech

Founded

1976

CEO

Colin Shannon

Job Filters

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