QA Operations Expert / Qualified Person
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 GxP requirements are met for IMP and product’s dossiers, so manufactured batches can be safely released. 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:
- Batch certification for drug product (both IMP and commercial stage) and release of drug substance
- Supervision of areas to assure that all stages of drug substance and product manufacture were performed fully compliant with GMP and master documentation
- Regular visits in production (upstream and downstream), engineering, supply chain and quality control areas (including IInd and IIIrd shift support, if needed)
- Reviewing of documentation and GMP records
- Participation in OOX, deviations, escalations, (s)CAPA, change control, complaints, quality agreements, product quality review and risk management processes
- Assessment and approval of related Quality records to assure that they are not impacting drug substance and product quality and patients safety
- Providing training of Quality processes
- Working in computer systems, e.g. TrackWise, SAP, LIMS
- Interdisciplinary cooperation between departments, sites and 3rd parties
- Support in product transfer process and new products launch
- Participation in audits (both as a SME and an auditor)
- Driving continuous improvement to facilitate processes, increasing their efficiency
If you have:
- Master degree (Pharmacy preferably) obtained in the field of biology, biotechnology, chemistry or related
- Certificate of completion of postgraduate studies (if additional supplementation is required to have Qualified Person permissions granted)
- 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, GCP and applicable FDA/EMA regulations in the pharmaceutical industry (including data integrity)
- Practical knowledge of the biotechnological production and analytical methods
- 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)