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!
As a Technical Investigator, Senior Specialist you perform and manage deviations, and investigations from the Technical Operations area, including manufacturing, engineering, MSAT, and Supply Chain. In this role, you coordinate also with other functional areas and lead the investigation process, including root cause identification, risk impact analysis, and CAPA definition.
Responsibilities
- Making comprehensive documentation of deviations including but not limited to the causal analysis, impact analysis, risk analysis, corrective actions, CAPAs to ensure content accuracy and the right flow of the information
- Collaborating as part of the investigation team- directly with SMEs and the other members of the investigation team to track data
- Actively participating in investigations, corrective action, and related meetings
- Coordinating deviation closure with QA Operations and participating in deviation and CAPA review boards as needed
- Following strict compliance with the site's health and safety regulations
Qualifications
- Academic degree in chemistry, biotechnology, molecular biology, biochemistry, pharmacy, medicine or related
- Fluency in English both spoken and written; certificate preferred
- At least 3 years of professional experience in Pharmaceuticals or Biotechnology is preferred; including direct experience with QMS specifically (deviations, CAPA’s, OOS’s, etc.)
- Ability to multitask, time management, and detail-oriented mindset
- Working proficiency in Microsoft Office applications
- Ability to prioritize and execute tasks in a fast-paced environment
We offer
- Private healthcare
- Life insurance
- Pension plan above national standards
- Relocation package
- Additional free day
- and more…
