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 helpdesk. 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.

           

Position Overview:

 

The technical lead will work in partnership with IT, QA, CSV and QC to ensure smooth running of labs systems and regulatory compliance. Day to day operational support is another key part of the role.

 

Duties & Responsibilities:

 

  • Provide day to day IT support of instrument systems in the labs and manufacturing areas, including tasks such as user access management, troubleshooting, preventative maintenance, data management, patch management and ensuring that systems are available 24x7 to meet business needs.
  • Provide direction, support and development of the team of Lab Engineers for Lab sustaining activities.
  • Ensure that all work on Lab IT and Benchtop Analytical equipment is carried out in a compliant manner, meeting 21 CFR Part 11, EU Annexe 11, cGLP/GMP’s.
  • Provide day to day compliance support of IT Laboratory Systems such as user access reviews, system performance monitoring, change control, data management.
  • Support the maintenance of AIT (Automation & IT) systems in a state of Audit Readiness.
  • Management of IT lifecycle procedures including change management, incident management, disaster recovery.
  • Ensure the AIT processes/procedures meet the business and site Quality Management System requirements and their evolution/improvement to meet the changing business and compliance needs.
  • Support the introduction of new instrument systems.

 

 

Experience and Key Skills Required:

 

  • Degree in Engineering, Information Systems, Computer Science or Life Sciences.
  • Four plus years’ experience of working in a pharmaceutical lab environment, with strong IT experience of laboratory instrument systems.
  • Technical Lead experience working in a pharmaceutical lab environment.
  • Onsite IT Windows and Infrastructure experience required. Remote experience not considered for this role.
  • Knowledge of Pharmaceutical Industry Guidelines & Regulations PICS-GMP, ISPE-GAMP, FDA - 21 CFR 11 and EMA - EU Annex 11.
  • Experienced working in a GMP environment, strong change management skills and ability to manage investigation and CAPA processes.


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