Regulatory and Compliance 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:
Participation in the continuous improvement of the pharmaceutical quality system in order to ensure the appropriate quality of manufactured products in accordance with applicable regulations 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-audits/post-inspections in terms of checking compliance with quality requirements. As SME taking part in customers quality audits and inspections.
Your responsibilities
- Submitting the initiatives for continuous improvement of quality processes in accordance with applicable legal requirements and best practices and the established pharmaceutical quality system of the company;
- As SME performing the assessment of facility readiness for any Inspections and Customer audits;
- As SME conducting the audits of production and quality control areas in order to properly assess implementation off post-audits/post-audits inspections recommendations;
- Conducting the external audits, reports writing and recommending the risk related to the use of the audited manufacturer/supplier in terms of QMS support as SME;
- Participation in issuing options on the change control process as part of the specialist knowledge;
- Continuous improvement of knowledge in the field of tasks performed through participation in training and following specialist literature;
- Conducting trainings within their area of knowledge;
- Participation in risk assessment and assessment of proposing effective CAPA activities;
- Participation in the implementation of quality process improvements;
- Timely completing other tasks and projects commissioned by Supervisor or Site Quality Head;
- Advising in aspects related to the law compliance and monitoring changes in law related to GMP and their interpretation;
- Participation in the assessment of SLAs;
- Participation in activities related to obtaining and holding the validity of the Manufacturing Authorization License and GMP certificates;
- Participation in creating a registration strategy, completing and checking the manufacturer’s registration data for EMA/USA;
- Cooperation with Registration Departments of Polpharma Biologics Group.
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.
- More than 5 years of professional experience;
- Very good knowledge of GMP requirements and regulations regarding pharmaceutical products. Good knowledge of FDA guidelines relevant to 21 CFR part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines;
- Strong knowledge of GMP processes with pharmaceutical manufacturing site;
- Knowledge of manufacturing and analytical technologies products and active substances;
- Strong communication skills and the ability of conducting effective training;
- Ability to think strategically and analytically. Organizational skills and the ability to work under pressure. Decisiveness;
- Creativity and undertakings independent initiatives. High communication skills in written and verbal;
- Very good command of spoken and written English.