Quality Control Physico-chemical Team Leader
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!
Responsibilities
- As part of the Fiz-Chem Team, planning and coordinating and testing of final products, intermediate products, raw materials and clean media.
- Periodical replacing of team manager.
- Development of quality system documents.
- Participation in the qualification of control and measurement equipment.
- Conducting corrective and preventive actions regarding the results of OOX, IA and complaints regarding product quality.
- Conducting activities within the TWD change control and quality events processes.
- The area preparation for GMP audits.
- Participation in internal and external audits and implementation of post-audit recommendations.
- Providing training in its field of expertise.
- Caring for the correct and efficient use of control and measurement equipment and HR.
- Compliance with work discipline, GMP regulations, health and safety and fire protection and applicable instructions, procedures and low regulations.
- Improving efficiency and safety at the workplace. Developing the Lean and 6s culture. Introducing and improving indicators of visualization of performance (KPI) in the team and minimizing costs and losses.
- Implementation of the initiatives regarding improvements in terms of GMP, organizational and technical as well as GMP and fire safety rules.
- Participation in obtaining contract laboratories for externally commissioned tests.
- Continuous improving knowledge, qualifications and experience.
- Participation in GMP, GLP, OHS and fire 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.
- Securing the entrusted property.
- Protection of confidential information and personal data.
If you have
- Higher education, with a specialization in the fields: biotechnology, biology, chemistry or related.
- Experience of working in an analytical laboratory or quality control laboratory in pharmaceutical or biotech works, (at least 3 years).
- Familiarity with chromatographic techniques.
- Knowledge of regulations and guidelines for good laboratory practice (GLP) and Good manufacturing Practice (GMP) contained in the ICH, FDA, EMEA and national guidelines.
- Basic knowledge of statistical analyses.
- Ability to set priorities and multi-task.
- Ability to independently develop work schedules and operational plans.
We offer
- Competitive salary;
- Private healthcare;
- Life insurance;
- Pension plan above national standards;
- Relocation package;
- Additional free day;
- and more..
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.