QC Microbiological Team Manager
Duchnice
Rozwijaj się z nami
Polpharma Biologics 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. Dołącz do nas!
Your role
Coordinating work in the Microbiological Team in the scope of tasks related to the microbiological tests of final products, intermediate products and raw materials. Managing and organizing work related to microbiological monitoring of the production environment. Implementation of new methods in the subordinate team, coordination of works related to the transfer, validation and qualification of analytical methods. Coordination and implementation of tasks related to the quality project.
Your responsibilities
- 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 validation of manufacturing processes,
- maintaining proper research documentation.
- 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 in a subordinate laboratory team
- Conducting lab investigations (OOS, OOT, and complaints for product quality) and associated corrective and preventive actions.
- Participating in change control processes by providing assessments on new tests methods and specifications, and overseeing their implementation in the subordinate team.
- 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 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.
- 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.
- Responsible for approving the 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.
- Gives opinions and approves instructions and procedures for the team's activities
- 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 entrusted property.
- Protection of classified information and personal data.
- Performing other tasks assigned by your supervisor.
If you have
- Well-established 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
- Knowledge of quality systems
- Ability to manage, motivate and engage employees