Remote: CSV Review Contractor (232109)

Life Sciences & Technology
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Job Description:

 

Be the Quality Reviewer and Approver of Automation System Development Lifecycle documentation (Requirements Specifications, Configuration Specifications, Test Plans, Requirements Traceability Matrices, Automation Change Controls) in the pharmaceutical regulated environment.

Responsibilities: 

  • Understanding of FDA regulations/guidance, various GAMP guidance documents, along with V model, 21CFR part 11 and other approaches to System Development Life Cycle (SDLC) validation
  • Providing Quality oversight of all computer system validation activities so that they can be completed on schedule and in compliance with local procedures and industry standards.
  • Responsible for effective document review and Quality approval in accordance with client Manufacturing Standards, Client Quality Policies, cGMPs for the generation of Quality Assurance Plans, Requirements specifications, Design Specifications, and Test Protocols
  • Experience with Quality systems including change control, incident management, and deviation management
  • Familiarity with the following systems preferred: PAS-X, DeltaV, PI, Rt Reports, BAS, and SAP
  • Effective global communication skills (both written and oral)
  • Strong analytical and problem solving skills
  • Ability to multitask and manage/prioritize multiple projects and deadlines
  • Strong customer service focus

 

Job Requirements:

 

Education: B.S. Degree required

Duration: 6+ months (40 hours per week)

Location: REMOTE

Start Date: December start date

 

Remote: CSV Review Contractor (232109)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
December
Location
Remote

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