Sweden Job Openings
Search4s Dustgoat AB
Quality Assurance Specialist for Computerized Systems,...
Stockholm
FULL TIME
September 6, 2024
Pharmetheus is a leading Life Sciences consultancy who specializes in biosimulation and biotech. We use advanced software to model biological processes supporting drug research, development, and life-cycle decisions. We are seeking your expertise to ensure our computerized systems meet regulatory standards.
Key Responsibilities:
- Develop and maintain the Quality Management System (QMS) for computerized systems.
- Conduct risk assessments and create management plans.
- Audit software and IT vendors for compliance.
- Lead internal audits.
- Validate and qualify computerized systems.
- Train consultants and staff.
- Manage the software lifecycle
- Liaise with regulatory authorities and stay current on regulations.
Qualifications:
- Degree in Engineering, IT, Natural Sciences, or related field.
- Extensive QA experience with computerized systems.
- Strong knowledge of QA principles and regulatory standards (e.g., ICH GCP, FDA 21 CFR Part 11, GAMP5).
- Proficient in test and validation techniques.
- Excellent English communication skills.
- Analytical and problem-solving skills.
- Proactive, solution-oriented, and self-driven.
- Pragmatic with strong prioritization skills.
- Structured and organized with effective communication.
Application and Information
Pharmetheus is partnering with Search4S and recruitment consultant Anna Rennermalm for this hiring process. Interviews and selections will be conducted on a rolling basis.For more details, please contact Anna Rennermalm at +46 70-794 20 05 or email her at anna@search4s.se.
Please ensure that your application is submitted via the provided link, not by email.
Application Deadline: October 6th 2024
About Pharmetheus
Pharmetheus is a diversified Life Sciences consultancy partner at the forefront of the application of quantitative approaches to drug research, development, and usage. We operate in the area of biosimulation and biotech, using software to describe biological processes. We offer consulting services focused on the application of quantitative approaches to support drug research, development, and life-cycle decisions. With our expertise in model-informed drug development, pharmacometrics, and PBPK-QSP, we support clients from strategy to design and analyses. At Pharmetheus, we are promoting a culture of innovation and collaboration where diversity and inclusivity are highly valued, and where everyone feels supported and empowered.Pharmetheus’ main premises is in Uppsala, Sweden. However, our physical footprint stretches beyond Uppsala through our office network in Basel, Paris and Utrecht and home office networks in Europe, Asia and North America.
www.Pharmetheus.com
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