COMPANY DESCRIPTION:



Westbourne IT Global Services is a transglobal organisation currently with Delivery Centres in Cork, Auckland and Foster City. Our business strategy is to significantly grow and expand our business over the next 2 - 3 years through a combination of organic growth and acquisitions. Our core differentiator is our ability to deliver scalable and world class 24*7 technical helpdesks. Our target market is a combination of Fortune 500 clients and high growth companies in the pharma, life sciences and IOT/manufacturing sectors. We have built our established reputation with an impressive list of long standing clients because of our unique culture. This culture places innovation, problem solving, people engagement and trust at the heart of our company. Our mission is to be a global leader in innovative IT customer support solutions that meet and exceed our business partner’s requirements.


RESPONSIBILITIES


  • Gather software specific requirements and draft SDLC documents
  • Organize project meetings, and perform standard meeting organizer duties (agenda, minutes action items etc.)
  • Research system/software functionality to determine suitability and its capability of meeting user requirements
  • Drive the team towards improved technical solutions to ensure data integrity
  • Configure software using standard out of the box tools and GUI to meet specific lab process requirements
  • Communicate to System Owner and user how the software meets their requirements
  • Assist in the development of Risk Assessments by providing software/system specific expertise
  • Draft preliminary test cases for IQ/OQ/PQ protocols
  • Draft SOPs, work instructions and other training materials
  • Document, and communicate project outcomes (Positive/Negative) to management and participate in effort to constantly improve the process
  • Assist in ad hoc projects as needed to address deviation investigations or initiatives.
  • Mentor junior staff
  • Educate System Owner regarding compliant software and business process choices that ensure data integrity is maintained
  • Provide Post-Go live system/application support


SKILLS AND EXPERIENCE


Must Have:

  • Ability to plan and prioritize assignments effectively to meet timeline commitments 
  • A strong desire to implement solutions that solve pressing compliance and process problems
  • 5 years in a regulated industry (preferably Pharmaceutical/Biotech, Medical Devices or Healthcare industries)
  • Strong interpersonal communication skills including, formal presentations, meeting management, negotiation/persuasion and conflict resolution
  • Self-motivation, and be a quick learner of business processes and technology
  • Strong Microsoft Office (or similar) application skills including Word, Excel, PowerPoint, Visio.
  • Experience implementing, or managing common software solutions used in the QC lab (Empower, SoftMax Pro, LIMS, ELN, LES, etc)
  • Experience as a software business administrator
  • 2 years bench level laboratory experience
  • 4 years direct experience implementing/validating software in a regulated environment
  • Experience as a Project Manager or Project coordinator
  • Experience in generating SDLC deliverables particularly URS, FRS and Config Spec 
  • Experience/Knowledge of good requirements gathering techniques including process mapping techniques. (LEAN, SIX SIGMA)
  • Experience in standard software development methodologies (Rapid, Waterfall, etc.)
  • Experience initiating and managing Change Control, and Deviations requests with TrackWise


EDUCATION


  • Minimum: BA/BS degree in either Lifesciences (Microbiology, Biology, Biochem, Analytical Chemistry etc.) or Computer Science/MIS related degrees ~ Or a minimum of 8 years direct experience in a similar role with escalating levels of responsibility will be considered
  • Highly Desired: ASQ, PMI, ITIL certifications.


 

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