Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Participation in the production of biotechnological products in accordance with GMP rules and FDA requirements in order to obtain a product of the quality set in the specification, for registration, preclinical research and implementation on a semi-technical scale. Participation in technology transfer in accordance with cGMP and internal regulations during the implementation of projects related to the introduction of new biotechnological products.
- Analyzing the obtained process results in terms of compliance with technological documentation and internal requirements.
- Participation in technology transfer, process characteristics and process validation in cooperation with the Research and Development Department and Manufacturing & Science Technology MS&T Department.
- Ongoing provision of reports and all necessary documentation to the supervisor and/or appropriate persons to evaluate the process.
- Informing the immediate supervisor about any irregularities and potential delays in the process, documentation, as well as the status of the tasks performed and decisions taken.
- Monitoring the process of manufacturing biotechnological products in accordance with the technological documentation.
- Carrying out the process in accordance with the principles of GMP and other internal requirements.
- Preparation of documentation in accordance with the principles of GMP and internal company requirements.
- Reporting the progress of all work and status of performed tasks to the immediate supervisor.
- Representing the company well.
- Preparation of reports on performed tasks.
- Securing the workplace.
- Organizing work in order to make the most effective use of working time and complete tasks.
- Cooperation with all teams of the Technical Operations Department and all other departments.
- Developing model procedures and instructions and conducting training on them.
- Preparation of equipment qualification documentation, conducting qualifications and/or participation in conducted qualifications.
- Development of operating instructions for devices and conducting training on them.
- Following the supervisors orders.
- Specialization: completed studies in biotechnology, pharmacy or related fields.
- Experience in research/development or production of biotechnology products or potential therapeutic molecules.
- Good knowledge of the principles of good cGMP manufacturing practice.
- Experience in keeping process documentation in accordance with GMP rules.
- Very good knowledge of aseptic work techniques, especially in conducting bacterial cultures.
- The ability to independently solve problems, good organization of work and time.
- Very good command of spoken and written English; knowledge of MS Office.
- Flexibility for new tasks, communication skills, ability to work in a team.
- Experience in the use of stainless steel installations and disposable materials for the production of biotechnological drugs is an additional advantage
- Experience in working with recombinant proteins will be an advantage
Zobacz podobne oferty
Pracownik Naukowy typu POST-DOC
W projekcie NCN: „Architektura otoczki jądrowej w progresji nowotworu gruczołu krokowego”, więcej o projekcie: https://projekty.ncn.gov.pl/opisy/497629-pl.pdf DO ZADAŃ OSOBY ZATRUDNIONEJ NA TYM STANOWISKU BĘDZIE NALEŻAŁO:...
Twoja rola Udział w procesie zarządzania, kontroli i rewizji dokumentacji dotyczącej wytwarzania produktów biotechnologicznych zgodnie z zasadami GMP oraz wymogami FDA w celu otrzymania produktu o jakości zadanej w specyfikacji celem...
QA Validation Expert
Your responsibilities: Plan, manage, support and implement the quality assurance of equipment, utilities validation and computerized systems program consisting of entire system lifecycle (from URS, through implementation, changes to...