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Delivery Consultant (IT QMS Implementation)

Who we are:

Headquartered in Bethlehem, PA, USA with offices in Naas, Ireland and New Delhi, India; Glemser Technologies is an IT solutions business.We analyse, comprehend, and implement IT systems compliance, validation and regulatory adherence for pharmaceutical, life science, biotech, medical devices, and high-tech manufacturing customers. We help businesses to adapt to technological change and to successfully implement the latest IT systems that will help them to gain a competitive advantage by getting products to market safer, faster and cheaper.

Job Function

Delivers the quality management software to customers, primarily in the Life Sciences industry. Performs implementations utilizing an SDLC-based methodology. Conducts requirements definition exercises, builds prototypes, facilitates end-user evaluation, delivers training, and participates in go-live activities. Maintains a high level of awareness of product offerings as well as industry trends and regulations.

Duties & Responsilities 

  • Collects and analyzes business and functional requirements of our customers by reviewing supplied documentation and conducting requirement workshops and interviews.
  • Produces project documentation according to a published implementation methodology.
  • Advises customers on design approaches
  • Works with customer to evaluate and develop logical work flows which will be configured.
  • Maintains constant communication with project team members and internal staff regarding project status.
  • Installs the product suite using automated installation tools.
  • Delivers and tests product configuration based on established requirements.
  • Performs report development and customization using reporting tools.
  • Development of computerised systems validation deliverables, such as
    • Risk and compliance assessment
    • 21 CFR Part 11 Compliance
    • User Requirements Specification
    • Traceability Matrix
    • Installation Qualification Report (IQ)
    • Operational Qualification (OQ)/System Test Protocols, Scripts and Reports
    • Performance Qualification (PQ)/User Acceptance Test Protocols, scripts and Reports
    • Validation summary Report
    • Install, Configure and Test software based on client requirements
  • Trains product administrator users in the overall product configuration and reporting tools to enable handoff of the system to a customer administrator post-implementation.
  • Conducts end-user training by developing and delivering content tailored to the specific business application and configuration performed.
  • Produces documentation for and participates in the computerized systems validation effort, including the execution of validation discrepancy handling.
  • Implements software in compliance with life science regulations including current good manufacturing practices electronic records and signatures.

 Qualifactions

Recent graduates or those who have graduated in the last 2-3 years can apply (training provided based on experience)

  • Computer Science or equivalent with excellent GPA
  • Strong technical aptitude
  • Understands software concepts and technology, such as Java
  • Excellent communication skills
  • Willing to travel to European client locations
  • Work expierence with enterprise software, configuration & implementation in a regulated environment a distinct advantage

How to Apply 

  • Email your cover letter and current CV 

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