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.
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.
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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