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 responsibilities include, but are not limited to:
- Building of a pharmaceutical quality system, qualification of control and measurement equipment.
- Timeliness of analytical work related to the validation of the product manufacturing process/active substance and the transfer of methods and the qualification of analytical methods.
- Conducting lab investigations (OOS, OOT, and complaints for product quality) and associated corrective and preventive actions.
- Participation in developing or reviewing Instructions and Procedures, including test methods and Operating Instructions for use and maintenance of equipment.
- Performing research in the field of microbiological monitoring of the production environment in accordance with GMP requirements and the plans and schedules of these tests.
- Performing microbiological analysis : purity and endotoxin testing
- Performing microbiological diagnostics.
- Work with microorganisms.
- Performing growth promotion test
- Testing of bioidicators
- Participation in internal and external audits and implementation of post-audit recommendations.
- Compliance with GMP, health and safety, and fire protection regulations.
- Processing: deviation, CAPA, change control
- 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. Introducing and improving upon key performance indicators (KPI) in the team in order to minimize costs and losses.
- Continuous improving knowledge, qualifications and experience.
- Participation in GMP, GLP, OHS and fire training and other specialist trainings related to the scope of the Microbiological Team's tasks.
.If you have:
- Higher directional education.
- Over 2 years of experience in quality control.
- Possible work shifts
- Established analitycal and microbiological knowledge.
- Knowledge of pharmacopoeial guidelines, GMP, EMA, FDA regulations and pharmaceutical laws.
- Ability to communicate in oral and written English Language.
- Computer skills including use of MS Office package.
- Familiarity of health and safety regulations, fire protection.
- Ability to clearly report and present results.
- Ability to communicate effectively internally within QC and external teams.
- Good knowledge of analytical and instrumental techniques.
- Basic knowledge regarding the principles of microbiological environmental monitoring.
- Knowledge of working with microorganisms, chemical reagents, disinfectants.
What we offer:
- Competitive salary
- Private healthcare
- Life insurance
- Pension plan above national standards
- Relocation package
- Additional free day
- and more..