Práca SME SME.sk
Pridať inzerát

Software Quality Assurance Engineer - Pharma background - Full remote

HighChem s.r.o., součást Thermo Fisher Scientific

Information about the position

  • Place of work: Remote work
  • Basic wage component (gross) and other rewards: From 2 900 EUR/month
  • Contract type: full-time

Job description, responsibilities and duties

When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale! You’ll do important work in helping to build software systems and products that help governments, hospitals, and laboratories around the world. You will support the development & testing teams to achieve compliance for software product development across all aspects of the Software Development Life Cycle. Your knowledge of compliance and regulatory guidance (ISO27001, SOC2, EU GDPR, 21CFR Part 11, Eudralex Volume 4 Annex 11, ISPE GAMP® 5) will propel our collective success in delivering software systems in a complex regulatory environment. Your experience with quality management system and software product development will help to enable the success of software engineering, systems, and product teams across the globe.


WHAT WILL YOU DO?
- Provide daily support to the development and commercial operations, including software validation packages, product monitoring, risk assessment and CAPA and problem investigations.

- Ensure Software development design control, verification/validation is in compliance with applicable QMS and regulations (e.g ISO 27001, USFDA regulations (e.g. 21CFR Part 11), Eudralex Volume 4 Annex 11, ISO27001, SOC2, EU GDPR, among others)

- Represent Quality Assurance in sprint planning, reviews, retrospectives, release planning, demos and other Scrum-related activities

- Develop and implement appropriate product quality/process improvement strategies with guidance from multi-functional team based on risks and opportunities – e.g. continuously improve Software Development Life Cycle processes with the multi-functional team

- Work closely with Software development team, Software testing team and product owners to increase the reliability of the software via improving test automation infrastructure/test coverage and standard processes to guarantee a quality user experience to our customers.

- Responsible for the qualification of software vendors and service providers – verification/validation

- Support the Quality Management System – e.g. quality plans/initiatives, change control/management, CAPAs, Supplier management, training, and audit program

- Participate as a Quality resource/facilitator for audit programs including internal routine audits and external audits (e.g. ISO, Customer, etc.). Responsible to support the maintenance of the necessary multi-site certification by participating in Audits (for e.g. but not limited to ISO 9001, ISO 27001)

- Acts as the Quality representative of the Product related CAPA review board (CRB), supports the organization to perform Root cause analysis and corrective/preventive action review

- Engage in quality initiatives to continuously elevate the quality culture and drive process improvements, support quality metrics and reporting for management reviews

Employee perks, benefits

- Employment with an innovative organization with exciting and fulfilling work

- Gross salary from 2.900 Euro/month

- Annual bonus

- Flexible working schedule and 3 sick days per year

- Outstanding career and development prospects

- Company stocks program

- Exciting company spirit which stands for integrity, intensity, involvement and innovation

- The opportunity to work with a truly global organization

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)

Language skills

English - Upper intermediate (B2)

Other knowledge

ISO 9001 - Skillful
Information Security (ISO 27001) - Skillful

Personality requirements and skills

WHO DO WE LOOK FOR:
- Proven experience working in regulated laboratory environment - suitable for candidate´s with various education background (biology, chemistry, biomedicine etc.)

- Knowledge in regulations such as ISO9001, ISO27001 and 21CFR part 11

- Excellent understanding of software lifecycle

- Strong written and oral communication skills in English

- Knowledge of the following .NET and JAVA would be a plus

- Experience working with Azure DevOps dashboards & Power BI is welcomed

- Enjoys working independently and as part of a team, adaptability, diligent and positive approach

Advertiser

Brief description of the company

Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more than $35 billion and approximately 90,000 employees globally. Our enterprise chromatography data system enables chemists in most laboratories around the world in any industry to perform high throughput analysis of chemical samples. From quality control in pharmaceutical laboratories to chemical analyses to doping controls at major international sports events, our software plays a critical role.
Our software development department is responsible for new product development and maintenance to support challenging customer requirements, as well as to control hundreds of highly complex chromatography instruments and components.

Number of employees

50-99 employees