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CAPA Consultant

Keywords / Skills : CAPA, GxP, CSV, LIMS, Trackwise, SumTotal

2 - 10 years
Posted: 2018-10-31

IT/ Computers - Software
Other Information Technology
Posted On
31st Oct 2018
Job Description
Job Description:

This person will be responsible for
  • Ensured that the procedures and documentation adhere to 21 CFR Part 11, Annex 11, GMP, GAMP, and GDP. 
  • Preparing validation strategies, planning, execution, documentation, and review and approval of the qualification of laboratory equipment & software, that can include FTIRs, HPLCs, GCs, PXRD, LIMS, ELN, and Empower 3. 
  • Formally track and document CAPA’s, project change records, task status, project timelines, and discrepancies. 
  • Review and approve installation, functional, and performance based test plans and test cases (IQ, OQ, PQ). 
  • Recommend process, documentation, and periodic review enhancements, assessed and improved activities and procedures related to software quality and data integrity. 
  • Conduct and participate in risk and impact assessment meetings. 
  • Implement Software Quality Assurance (SQA) methodology in validation activities. 
  • Identify gaps, determined remediation strategy, and recommended remediation efforts. 
  • • Review and approve Requirements Specifications, Validation Plans, and Summary Reports. 
  • Assess and execute Change Controls in a regulated fashion. 

  • 5 – 7 years’ experience validating GxP systems within the pharmaceutical, biotech, or medical device fields 
  • Able to create computer system validation (CSV) deliverables (Validation Plans, Requirements, Design Specs, Test Scripts (IQ / OQ / PQ), Summary Reports, Trace Matrices, SOPs) 
  • Familiar with one or more of the following types of systems: LIMS (e.g. Watson, SampleManager), , Validation Lifecycle Software (e.g. ValGenesis), QMS (e.g. TrackWise), Learning Management System (e.g. SumTotal) 
  • Working experience with Quality Management System (QMS) records (e.g. Deviations, CAPAs, Change Management) 
  • Able to understand current work processes and suggest process improvements 
  • Able to work both as part of a team and independently 
  • • Excellent communication skills (verbal, written) 

About Company

NNIT is a fast-growing IT company with ambitious goals and a strong specialization in IT for life sciences.

You’ll work in agile teams with other passionate people in a culture with room for independent thinking and individual responsibility.

We supply IT services to large enterprises that demand high levels of quality and security, and we take on the responsibility for our clients' IT as if it were our own. We live our values every day, so you should be able to see yourself in them.

We are: Conscience driven. Value adding. Open and honest.

We are passionate people building winning teams with our customers.

Our guiding light
Our vision is our guiding light - the goal that is always in our sights. We have chosen to use our vision to establish some very specific goals.

Walkin for you