QC Microbiological 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!
Coordinating work in the part of Microbiological Team in the scope of tasks related to the microbiological tests of final products, intermediate products and raw materials. Implementation of new methods in the subordinate team, coordination of works related to the transfer, validation and verification of analytical methods.
Your responsibilities include, but are not limited to:
- Acting as Deputy Manager of the Quality Control Microbiological Laboratory.
- Responsible for organizing and supervising the work of the subordinate team in the field of:
- microbiological tests and quality assessment of starting materials, packaging, products: intermediate, loose and final, advertised, as well as archival samples,
- compliance of tests performed with applicable requirements,
- validation/ verification of microbiological methods,
- research on the manufacturing processes,
- maintaining proper research documentation.
- Ensuring the proper implementation of the goals set, answering for the continuous improvement of teamwork and streamline processes in a subordinate laboratory team.
- Building of a pharmaceutical quality assurance system, qualification of control and measurement equipment.
- Ensuring the proper implementation of the goals set, answering for the continuous improvement of teamwork and streamline processes.
- Conducting lab investigations (OOS, OOE, OOT, and complaints for product quality) and associated corrective and preventive actions.
- Participating in change control processes.
- Participation in the development and responsibility for the execution of programs and microbiological control tests of the production environment in accordance with the requirements of GMP. Responsible for assessing the effectiveness of disinfectants.
- Finding new solutions for better planning and organization of work. Improving efficiency and safety at the workplace. Developing the Lean and 6s culture.
- Compliance with GMP, health and safety, and fire protection regulations.
- In consultation with the Head of the Quality Control ensuring appropriate level of staffing and qualifications of employees, by training and ensuring the organization of appropriate forms of qualification improvement for employees working in the team.
- Responsible for documents prepared and leaving the laboratory as well as giving opinions on the quality specifications in the field of microbiological parameters.
- Participates in internal and external audits and is responsible for implementing and controlling the implementation of post-audit recommendations.
- Assignment of tasks/duties and coordinating the schedules of subordinate employees.
- Responsible for maintaining the costs of microbiological tests at the level specified in the approved annual budget of the Company by analyzing individual cost components and optimizing operations and participating in designing the budget of the QC Department.
- Is responsible for continuous improvement of own qualifications and improvement of knowledge and experience.
- Tracking the current GMP guidelines and regulations related to the operation of Quality Control.
- Protection of classified information and personal data.
- Protection of entrusted property.
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 5 years).
- Computer skills including use of MS Office package.
- Familiarity of health and safety regulations, fire protection.
- Ability to communicate in oral and written English language.
- Knowledge of pharmacopoeial guidelines, GMP, EMA, FDA regulations and pharmaceutical laws.
- Ability to set priorities and multi-task.
- Ability to communicate effectively internally within QC and external teams.
- Ability to clearly report and present results.
- Ability to set priorities and multi-task.
What we offer:
- Competitive salary.
- Private healthcare.
- Life insurance.
- Pension plan above national standards.
- Relocation package.
- Additional free day.
- and more..
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Polpharma Biologics
#PolpharmaBiologics to jeden z najnowocześniejszych ośrodków badań i rozwoju oraz produkcji leków biologicznych w Europie. Jesteśmy międzynarodowym zespołem doświadczonych ekspertów oraz ambitnych młodych naukowców posiadających wspólne cele i wartości. Biotechnologia jest naszą pasją, dzięki której wspólnie opracowujemy leki będące nadzieją dla pacjentów cierpiących na ciężkie choroby.
Razem tworzymy przyjazne miejsce pracy, w którym możemy się rozwijać oraz realizować swoje ambicje. Chcielibyśmy, abyś do nas dołączył.