Quality Expert and 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:
In this role you will participate in quality projects regarding continuous improvement of the pharmaceutical quality system in order to ensure the appropriate quality of manufactured products in accordance with applicable provisions and guidelines of GMP, Pharmaceutical Law, EMA, PIC / S, WHO, ISPE, PDA, EU GMP, FDA by monitoring and interpreting introduced changes and assessing the implementation of recommendations post-audit/post-inspections in terms of checking compliance with quality requirements.
Your responsibilities
- Continuous improvement of knowledge in the field of performed tasks through participation in training and following professional literature.
- As SME performs the assessment of Facility readiness for any Inspection and Customer audits.
- As SME issues an opinion on corrective and preventive actions in the field of GMP, Pharmaceutical Law, EMA, PIC / S, WHO, ISPE, PDA, EU GMP, FDA as well as regulatory provisions and registration dossier.
- Verifying the scope of effective CAPAs, (post-audits and post Inspections).
- As SME participates in giving opinions and implementing the change control process within the scope of her specialist knowledge.
- Participating in the verification of the compliance of the quality documentation of products intended for clinical trials, transfer, process and validation documentation with regard to the registration dossier, the scope of obtained manufacturing and marketing authorizations.
- Participating in the risk assessment process.
- Participating in creating the registration strategy, completing, checking the manufacturer's documentation which is the registration data for the EMA / FDA.
- As Qualified Person and Authorized Person evaluating batch records.
- As QP suggesting recommendations in case of incidents affecting the quality of manufactured active substances.
- Taking independent decisions to issue of a CoC document for the manufacturing stage (quality control testing) of a batch of an investigational medicinal product and active substances for the manufacture of the investigational medicinal product.
- Taking independent decisions to release or rejection of active substances for the manufacture of the investigational medicinal product
If you have
- Higher diploma and master’s degree in one of the fields of biology, pharmacy, chemistry, chemical technology, chemical and process engineering or completed university studies in medicine.
- At least 10 years of experience in a medicinal product factory including 2 years in the field of pharmaceutical product evaluation in the area of quality control or assurance.
- Very good knowledge of Pharmaceutical Law, GMP requirements and regulations regarding pharmaceutical products.
- Knowledge of manufacturing and analytical technologies related to the assessment of pharmaceutical products and active substances.
- Strong knowledge of validation issues in pharmaceutical production.
- Leadership skills. Management maturity and the ability to think strategically and analytically. Organizational skills and the ability to work under pressure. Decisiveness.
- Fluent use of Polish and English spoken and written.