Quality Control Expert (Equipment Management)
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 tasks related to the management equipment, supervision of calibration, qualification and validation schedules for computerized systems, also participating in qualification activities. You will also support for the operation of equipment, CAPEX budget control of the department along with the preparation of appropriate documentation in the GMP system
Your responsibilities:
- Management of equipments in the quality control department, including computerized systems
- Supervision of equipment/rooms necessary to provide Analysis in Quality Control
- Participation in the implementation and working with LIMS, SAP and other systems supporting processes
- Perform and document equipment work used in Quality Control in accordance with GMP
- Developing, reviewing, approving Instructions, Procedures and other system documents
- 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
- Approving, reviewing and co-creating qualification, validation documentation related to measuring equipment and computerized systems
- Requesting and supporting service repairs
- Carrying out maintenance and simple repairs of measurement equipment which can be done by the user
If you have:
- Higher education in the field: biotechnology, pharmacy or related
- 5 years of professional experience in the biotechnology industry, equipment work related beneficial
- Good knowledge of MS Office.
- Knowledge of EMA, FDA guidelines, pharmacopoeia monographs
- Good written and spoken English language.
- Good communication skills within QC and external teams
- Ability to identify and solve problems independently