IT Quality Specialist for Bioporto Diagnostics A/S
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Hellerup
We are looking for a highly skilled IT Quality Specialist to join the Quality Assurance team in Denmark.
About us
BioPorto is an in vitro diagnostics company that provides tests and antibodies to clinicians and researchers around the world. We use our antibody and assay expertise to transform novel research tools into clinically actionable biomarkers that can make a difference in patients’ lives. BioPorto is headquartered in Hellerup, Denmark and is listed on the NASDAQ Copenhagen stock exchange.
Our people
BioPorto has approximately 30 dedicated employees globally, most of whom work in Hellerup. Our organization can be characterized as energetic, passionate, and committed to providing a supportive work environment. If you wish to be part of our organization, we are eager to hear from you.
Your role
We are actively seeking a committed and detail-oriented individual to join our team as a key responsible for our electronic Quality Management System (eQMS). As an integral part of our dynamic team, comprised of three dedicated professionals, you will collaborate closely with departments such as sales, marketing, research and development (R&D), and production.
In this role, you will play a crucial role in managing, updating and secure full implementation of the eQMS. Your responsibilities will involve ensuring the best standards for quality processes are implemented throughout our processes, contributing to regulatory compliance, and a high degree of efficiency. You will be working collaboratively with cross-functional teams to uphold excellence in our products and services.
Key responsibilities
Your qualifications
As a person, you are structured, thorough, and responsible as well as good at meeting deadlines. The position also requires that you have influence and are not afraid of being "hands-on". Finally, you are used to communicating constructively and entering collaborations with a focus on finding the right solutions, and you can simplify and handle complex situations.
Our offer
We offer a wide range of professional, social and financial employee benefits in addition to an exciting and dynamic position, with great opportunities for personal and professional development. You will work in a small and informal team, with interface to other departments (Production, R&D, etc.), where your expertise and opinion will be valued.
About us
BioPorto is an in vitro diagnostics company that provides tests and antibodies to clinicians and researchers around the world. We use our antibody and assay expertise to transform novel research tools into clinically actionable biomarkers that can make a difference in patients’ lives. BioPorto is headquartered in Hellerup, Denmark and is listed on the NASDAQ Copenhagen stock exchange.
Our people
BioPorto has approximately 30 dedicated employees globally, most of whom work in Hellerup. Our organization can be characterized as energetic, passionate, and committed to providing a supportive work environment. If you wish to be part of our organization, we are eager to hear from you.
Your role
We are actively seeking a committed and detail-oriented individual to join our team as a key responsible for our electronic Quality Management System (eQMS). As an integral part of our dynamic team, comprised of three dedicated professionals, you will collaborate closely with departments such as sales, marketing, research and development (R&D), and production.
In this role, you will play a crucial role in managing, updating and secure full implementation of the eQMS. Your responsibilities will involve ensuring the best standards for quality processes are implemented throughout our processes, contributing to regulatory compliance, and a high degree of efficiency. You will be working collaboratively with cross-functional teams to uphold excellence in our products and services.
Key responsibilities
- Managing the daily operation and maintenance of our eQMS (MasterControl)
- Ensure continues updates and improvements of the eQMS
- Supporting day to day operation, user management, Trouble shooting, user support
- Data analysis and data extract for reporting out on processes from eQMS
- Perform development, test and validation of the system
- Ensure training and education of the organization in proper use of the system
- Support QMS process development and procedures associated to the use of the system
- Review and approval of IT validation protocols and reports
- Assist the company in maintaining and developing a proper quality spirit through training of colleagues.
- Participation in the company's transition to IVDR
- Participate in 3. Party Audits from Regulatory authorities and Notified Bodies
Your qualifications
- Academic background (engineer, cand. Pharm., Cand. Scient. Or similar)
- Several years of experience from a QA or IT function within the regulated industry, preferably ISO 13485 and FDA part 21CFR 820 knowledge
- has experience as administrator of IT tools and eQMS tools, preferred MasterControl experience or similar
- Experience with Document control, Non-conformance, software validation, handling of deviations is a plus
- Ability to learn new systems and understand how to best use them.
- Ability to train others in the use of eQMS system
- Ability to write, read, and speaking in English at a fluent level
- Can work independently while maintaining a high quality and attention to detail.
- Ability to work in a dynamic environment where effective teamwork is critical to succeed.
- Can stay focused and meet timelines while managing multiple activities.
As a person, you are structured, thorough, and responsible as well as good at meeting deadlines. The position also requires that you have influence and are not afraid of being "hands-on". Finally, you are used to communicating constructively and entering collaborations with a focus on finding the right solutions, and you can simplify and handle complex situations.
Our offer
We offer a wide range of professional, social and financial employee benefits in addition to an exciting and dynamic position, with great opportunities for personal and professional development. You will work in a small and informal team, with interface to other departments (Production, R&D, etc.), where your expertise and opinion will be valued.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Hellerup.
Jobbet er oprettet på vores service den 8.12.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Produktspecialist
- Hellerup
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