Quality Control Senior Specialist
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:
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.
Your responsibilities:
- 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
If you have:
- 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