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As a Quality Control Support Leader you will be responsible for implementation of work in the scope of the tasks related to the sample management and QC support process: registration, distribution and archiving of analytical samples, samples for stability tests and implementation of the work of the team in order to ensure the required level of service for other teams of the Quality Control Department. Your work will be related to stability programs of biotechnological products and computerized systems.
- Building of quality control systems for sample management, qualification of control and measurement
- Supervision of archiving samples in QC
- Supervision of the development of stability study protocols, splitting/distribution of samples for stability studies in QC. Supervision of equipment/rooms necessary to store stability study samples
- Responsibile for maintaining the cost levels within the approved annual budget of the Company by analyzing the individual components of costs and optimizing activities, and is involved in the budgeting of the QC Department
- Participation in the implementation and working of the LIMS system and supporting processes
- Preparation of sampling plans for the production process
- Perform and document analytical work used in Quality Control in accordance with GMP
- Preparation of product intermediates, media and buffers specifications
- Preparation of documentation for registration purposes
- Developing, reviewing, approving Instructions, Procedures and other system documents
- Verifying, updating and checking laboratory documentation (including cleaning logbooks, equipment logbooks, laboratory registers) in electronic and paper versions
- Initiate/participate in change controls, deviations and ongoing investigations
- Participation in lab investigations (OOS, OOT, and complaints for product quality) and associated corrective and preventive actions.
- Create, supervise change control process, deviations, investigations and CAPA in TWD system
- Participation in internal and external audits and implementation of post-audit recommendations
- Compliance with GMP,DI, health, safety, and fire protection regulations
- Rewarding and disciplining subordinate employees. Making organizational changes to improve efficiency/productivity within the subordinate team
- 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
- Higher education in the field: biotechnology, pharmacy or related
- 5 years of professional experience in related positions
- Good knowledge of computer and MS Office.
- Knowledge of EMA, FDA guidelines, pharmacopoeia monographs, GMP regulations and pharmaceutical law issues
- Ability to communicate in oral and written English language.
- Ability to communicate effectively internally within QC and external teams
- Ability to identify and solve problems independently
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.