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As a Quality Control Expert you will be responsible for implementation of work in the scope of the tasks related to the sample management process: registration, distribution and archiving of analytical samples, samples for stability tests.
- Building of quality control systems for sample management, qualification of control and measurement equipment
- Samples distribution and aliquoting at QC
- Archiving samples in QC
- Supervision of the development of stability study protocols, splitting/distribution of samples for stability studies in QC. Supervision of equipment/rooms necessary to store stability study samples
- Shipping/receiving samples to/from the contract lab
- Participation in the implementation and working of the LIMS system and supporting processes
- Preparation of sampling plans for the production process
- Perform and document analytical work used in Quality Control in accordance with GMP
- Preparation of product intermediates, media and buffers specifications
- Preparation of documentation for registration purposes
- Monitoring environmental conditions in equipment and rooms
- Developing, reviewing, approving Instructions, Procedures and other system documents
- Verifying, updating and checking laboratory documentation (including cleaning logbooks, equipment logbooks, laboratory registers) in electronic and paper versions
- Initiate/participate in change controls, deviations and ongoing investigations
- Participation in lab investigations (OOS, OOT, and complaints for product quality) and associated corrective and preventive actions
- Create, supervise change control process, deviations, investigations and CAPA in TWD system
- Participation in internal and external audits and implementation of post-audit recommendations
- Compliance with GMP,DI, health, safety, and fire protection regulations
- Finding new solutions for better planning and organization of work in the team. Improving efficiency and safety at the workplace. Developing the Lean and 6s culture
- Higher education in the field: biotechnology, pharmacy or related
- 3 years of professional experience in related positions
- Good knowledge of computer and MS Office.
- Knowledge of EMA, FDA guidelines, pharmacopoeia monographs, GMP regulations and pharmaceutical law issues
- Ability to communicate in oral and written English language.
- Ability to communicate effectively internally within QC and external teams
- Ability to identify and solve problems independently
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.