About the role
As a QRM Specialist at 4TE you will be solving problems, analysing processes and implementing improvements within the Pharma and Biopharma Industry – all this using a scientific and risk-based approach.
You will be part of a multidisciplinary team that includes pharmaceutical specialists, bioengineers and IT specialists. You will work with some of the biggest names of the Pharmaceutical industry for the creation of cutting-edge solutions that bring healthcare one step closer towards the future.
We’re looking for someone who pays close attention to detail, who has result-orientation and who, most of all, is a team player even though we work remotely full time!
As a QRM Specialist, the duties and responsibilities will include:
- Provide a science and risk-based approach for the resolution of our costumers’ challenges, such as deviations, investigations, and process issues through analysis of historical data and/or root cause investigations.
- Work with our IT Team to provide technical inputs for the development of new digital product features, including tasks related with GAMP 5 compliant software development, verification testing and validation.
- Generate documents (SOPs, operation protocols and/or manuals, reports, etc.) within the scope of the client’s requirements.
- Design and prepare training materials and educational content, based on regulatory guidelines and industry best practices, to meet the client’s needs.
- Engage directly with the client along the different project phases: initiation, planning, execution, monitoring and close-out.
- Facilitate and critically review risk-based exercises, including analysis of implemented practices regarding risk assessment and benchmark against the best practices and state-of-the-art in the area.
- Facilitate and/or provide coaching on risk management exercises using adequate tools (FMEA, PHA, FTA, etc.), ensuring that methodologies are correctly applied and that solid results are obtained.
- Knowledge about regulatory packages in Pharma and Biopharma industry, namely on the area of risk, lifecycle management and software development with 2-3 years of professional experience.
- Understanding of cGMP requirements, ICH guidelines, GAMP 5 and other applicable pharma and biopharma regulatory requirements and guidelines
- Biologics and Pharma process understanding
- Strong technical and quality writing skills (SOPs, validation protocols, etc)
- Experience with JIRA is valued.
- Prior knowledge in computer system verification and/or validation and GxP documentation writing and reviewing is highly valued.
- Strong presentation, written and spoken communication skills
We are looking for someone with a Master of Science degree in Biological Sciences, Biological/Biomedical/Chemical Engineering or Biotechnology or Pharmaceutical Sciences.
What we can offer:
- Fair compensation adjusted to experience and skills.
- Multiple training and development opportunities.
- Structured process for Career Progression.
- A fully functional remote work environment.
- A friendly and young team.