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If your area of expertise is managing deviations and investigations from the Technical Operations area, including manufacturing, engineering, MSAT and Supply Chain and you would like to bring your skillset and experience to a company working in a novel field of biopharmaceuticals, which aims to improve the quality of lives of many patients, this role will allow you to utilize your knowledge. You will be responsible for coordination with other functional areas and lead the investigation process, including root cause identification, risk impact analysis and CAPA definition.
- 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 deviation and investigation content and workflow solutions.
- 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.
- 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.
- Strict compliance to health and safety rules in the site.
- Higher education with a specialization in the fields: chemistry, biotechnology, molecular biology, biochemistry, pharmacy, medicine or related.
- 3+ 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).
- Communicate at a professional level in reading, writing, speaking, listening in English.
- 3+ 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..
- Organization and time management to manage multiple tasks, sometimes for multiple projects, at once.
- Leadership and motivation to guide team members in making consistent progress.
- Goal-setting to set realistic deadlines and strategize daily, weekly, monthly and quarterly progress.
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.