Your responsibilities

As a Process Deviations Investigation Expert, your key duties will include:

• Deviation Documentation and Analysis: Generate comprehensive documentation for process deviations, including causal analysis, impact analysis, risk analysis, corrective actions, and CAPA. Ensure accuracy, logical flow, and adherence to procedural requirements in all documentation.
• Deviation Management: Serve as the owner of process deviations, overseeing the entire lifecycle from identification through closure. This includes coordinating with QA Operations to ensure timely and effective resolution.
• Collaboration and Coordination: Work both independently and collaboratively with the investigation team, coordinating closely with Subject Matter Experts (SMEs) to ensure all aspects of the deviation are thoroughly documented and addressed. Participate in and contribute to Deviation and CAPA review boards as required.
• Reporting and Data Analysis: Generate reports from Quality Systems and perform data analysis pertinent to key performance indicators (KPIs) to monitor and improve process performance.
• Procedural and Process Improvement: Analyze and update procedures, forms, training, and other documentation based on findings from investigations. Propose and implement improvements to existing manufacturing, engineering, MSAT, and supply chain processes.
• Innovation and Proactivity: Generate innovative ideas for content and workflow improvements. Be proactive in identifying issues and engaged in the investigation and remediation processes. Propose new solutions to enhance the effectiveness of interdepartmental investigative activities.

If you have

• Educational Background: A bachelor's degree or higher in Chemistry, Biotechnology, Molecular Biology, Biochemistry, Pharmacy, Medicine, or a related scientific field.
• Experience in Quality Management Systems: Over 6 years of direct experience with QMS, including proficiency in handling deviations, CAPA’s, OOS’s, etc., within the Pharmaceutical or Biotechnology industry.
• Regulatory Inspection Experience: Practical knowledge and involvement in regulatory inspections conducted by bodies such as GIF  (FDA, and EMEA is a plus)
• Advanced English & Polish Proficiency
• Technical and Analytical Skills: Exceptional analytical and conceptual thinking abilities, coupled with a strong understanding of biotechnology production processes.
   

If your qualifications and experience align with these criteria, you are likely a strong candidate for this role. We encourage you to apply and potentially join our team in driving forward advancements in our field.

We offer

• Competitive salary;
• Private healthcare;
• Life insurance;
• Pension plan above national standards;
• Relocation package;
• Additional free day;
• and more...