QA Operations Expert
Duchnice
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!
Your role:
You will have the unique opportunity to participate in strengthening Quality Culture in the new biotechnological facility by partnering production, engineering, supply chain and quality control departments. You will be responsible for ensuring that GMP requirements are properly applied in the procedures and processes. Your daily tasks will be connected with areas oversight, both by provision of the shopfloor support and serving as a SME in documents review, changes assessment, investigations and risk analysis. You will be empowered to take Quality decisions and exciting assignments, as well as provided trainings, will support your personal development.
Your responsibilities:
- Developing and reviewing Quality System documentation ensuring compliance with internal and legal requirements
- Reviewing of GMP records (e.g. batch documentation, including audit trial review)
- Regular visits in production (upstream and downstream), engineering, supply chain and quality control areas (including IInd and IIIrd shift support, if needed)
- Participation in deviations, (s)CAPA, change control and risk management processes
- Participation in escalation process, including exposure to group level management
- Providing training of Quality processes
- Working in computer systems, e.g. TrackWise, SAP, LIMS
- Interdisciplinary cooperation between departments and sites
- Participation in projects implementing new products
- Participation in audits (both as a SME and an auditor)
- Driving continuous improvement to facilitate processes, increasing their efficiency
If you have:
- University degree (Biology, Chemistry, Pharmacy, Biotechnology or related)
- 8 years of working experience in the pharmaceutical industry, incl. 5 years in Quality Control and/or Quality Assurance respectively
- Experience and knowledge of cGMP and applicable FDA/EMA regulations in the pharmaceutical industry (including data integrity requirements)
- Practical knowledge of the biotechnological production and analytical methods will be a great advantage
- Skills in decision-making, problem solving, planning and organizing, coaching others and analytical thinking
- Strong verbal and written communication skills (as a minimum in Polish and English languages)
- Flexibility to do up to 10% of travels
- Flexibility to working on shifts (when required)