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:
In this role you will become a part of Physicochemical Quality Control Team. You will plan, perform, and report on analytical tests of final as well as intermediate products, raw and packaging materials, and clean media. You will be tasked with implementing new methods of transfer, validation, and verification of analytical methods. You will take care of evaluation of QMS documentation and implementation of tasks related to quality projects.
Your responsibilities:
- Analytical work related to the validation of the product manufacturing process and active substance
- Validation, transfer, and qualification of analytical methods
- Conducting corrective and preventive actions regarding the results of OOS, OOT and complaints related to product quality
- Participation in development and reviewing Instructions and Procedures, including the Operating Instructions for control and measurement equipment
- Participation in change control processes (e.g. by issuing opinions on new test methods and specifications and their implementation in the team)
- Participation in internal and external audits and implementation of post-audit recommendations
- Improving efficiency and safety at the workplace
- Developing the Lean and 6S culture.
- Introducing and improving indicators of performance (KPIs) in the team and minimizing costs and losses
- Participation in obtaining contract laboratories for externally commissioned tests
- Continuous improvement of knowledge, qualifications, and experience
- Participation in GMP, GLP, OHS and fire safety training and other specialist trainings related to the scope of the Team's tasks
- Training of employees of the Team in the scope of tasks performed, GMP and Health and Safety rules
- Checking laboratory documentation from tests in terms of its content and compliance with the requirements of data integrity and GDocP
- Periodical employee management as part of ongoing quality projects
If you have:
- University degree with a specialization in the field of biotechnology, biology, chemistry or related
- At least 3 years of working experience in an analytical laboratory or quality control laboratory in pharmaceutical and/or biotech industry
- Working knowledge of chromatography techniques (HPLC/CE)
- Good knowledge of Empower software
- Knowledge of regulations and guidelines for Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) contained in the ICH, FDA, EMEA and national guidelines
- Good command of English
- Basic knowledge of statistical analyses
- Ability to set priorities and multitasking