Technical Investigator Senior Specialist
Gdańsk
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Perform and manage deviations and investigations from the Technical Operations area, including manufacturing, engineering, MSAT and Supply Chain. Coordinate with other functional areas and lead the investigation process, including root cause identification, risk impact analysis and CAPA definition.
Your responsibilities include, but are not limited to:
- Responsible for generating a comprehensive documentation of a deviation including but not limited to the causal analysis, impact analysis, risk analysis, corrective actions, CAPA’s ensuring accuracy of content and logical flow to the documentation.
- Serve as deviation owner of deviations generated from Technical Operations, including Production, Engineering, MSAT and Supply Chain.
- Ensure the writing encompasses all aspects of procedural requirements and best practices for quality record documentation.
- Works both independently and collaboratively as part of the investigation team. This position collaborates directly with SME’s and the other members of the investigation team to document the information.
- Determine the clearest and most logical way to present information for greatest reader comprehension.
- Generate innovative ideas for content and solutions to the flow of your work and work of the team.
- Coordinate with subject-matter experts to ensure specialized topics are appropriately addressed.
- Generate reports from Quality Systems and perform data analysis related to the applicable KPIs in the timely manner.
- Be proactive and engaged during investigation and remediation associated with the investigation and the associated meetings.
- Coordinate deviation closure with QA Operations.
- Participate in Deviation and CAPA review boards as needed.
- Analyze information required for the development or update of procedures, forms, training or other documentation.
- Analyze information required to update/improve existing processes in Manufacturing, Engineering, MSAT and Supply Chain.
If you have:
- Higher education with a specialization in the fields: chemistry, biotechnology, molecular biology, biochemistry, pharmacy, medicine or related.
- Advanced level of English (spoken and written), certificate preferred.
- 4+ years direct experience with QMS specifically (deviations, CAPA’s, OOS’s, etc.).
- A minimum of a bachelor’s degree in a scientific field (or degree related to their area of expertise).
- 4+ years in Pharmaceutical or Biotechnology field.
- Understanding deviation timeline requirements and ability to explain these needs to all members of the Investigation Team as well as other employees.
What we offer:
- Competitive salary.
- Private healthcare.
- Life insurance.
- Private pension plan.
- Relocation package.
- And more…
