Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
In this role, you will have an opportunity to take part in the whole life cycle of biopharmaceutical product development and production. You will be responsible for quality oversight over the sterile manufacturing including deviation, CAPA, change management, risk assessment, batch documentation review, and preparation for audits and inspections.
- Ensuring quality oversight over the sterile manufacturing area
- Ensuring cGMP and regulatory compliance of operations leading to biological Drug Product
- Ensuring that a high quality of products is achieved through qualification and validation based on quality risk analyses, product quality assessments, and ongoing verification
- Ensuring that all processes and products at the site meet all internal and external requirements
- Batch records’ and all related documentation review
- Participation in investigations on deviations and complaints, OOS/OOT, recalls and escalations
- Supporting change control requests, assuring GMP and regulatory compliance
- Participation in risk assessments
- Supporting all product and process-related activities e.g. process transfers, process validations, and continuous process verification (including e.g. stability studies, hold time studies, approval of protocols and reports)
- Supporting the preparation of Annual Product Quality Reviews
- Participation in internal and external audits
- Support establishment of Quality Management System documentation in accordance with the requirements of Polpharma Biologics and the HA requirements in reference to diverse market areas
- Ensuring correctness and data integrity of all regulatory and manufacturing data
- University degree (Biology, Chemistry, Pharmacy, Biotechnology or related)
- 3 years of working experience in the pharmaceutical industry, incl. 2 years in Quality Control and/or Quality Assurance of pharmaceutical products
- Excellent knowledge of GMP requirements and pharmaceutical laws and regulations
- Knowledge of biopharmaceutical products manufacturing technologies, knowledge of sterile pharmaceutical production
- Understanding the issues and needs related to qualification and validation processes in sterile manufacturing
- Knowledge of Quality Management Systems
- Experience in Biotechnological manufacturing or commercial production
- Fluent English
Poznaj
Polpharma Biologics
#PolpharmaBiologics to jeden z najnowocześniejszych ośrodków badań i rozwoju oraz produkcji leków biologicznych w Europie. Jesteśmy międzynarodowym zespołem doświadczonych ekspertów oraz ambitnych młodych naukowców posiadających wspólne cele i wartości. Biotechnologia jest naszą pasją, dzięki której wspólnie opracowujemy leki będące nadzieją dla pacjentów cierpiących na ciężkie choroby.
Razem tworzymy przyjazne miejsce pracy, w którym możemy się rozwijać oraz realizować swoje ambicje. Chcielibyśmy, abyś do nas dołączył.