Process Validation Expert
Duchnice
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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!
Process Validation Expert is leading or supporting Process Performance Qualification (Process Validation) activities of PBW drug substance manufacturing activities in accordance with Regulatory requirements, including cleaning validation.
Your main responsibilities include, but are not limited to:
- Developing pre-validation / validation strategy, including the strategy for supportive studies;
- Coordinating activities between all departments involved in individual activities of drug substance manufacturing process validation and cleaning validation in PBW;
- Creating protocols and validation reports;
- Initiating monitoring and continuous process verification phase and compilation of the first APQR;
- Being a single point of contact for a given validation process;
- Contributing to the overall strategy and plans of TT projects scope of which includes the process validation phase, including the creation of schedules and budgets;
- Developing validation plans, scientifically sound technical strategies (with validation team), contingency plans, identifying obstacles and proposing possible solutions;
- Planning of resource needs (full time, investment, external costs), strategies and schedules;
- Forming and / or leading a validation team, setting team priorities and meetings, coordinating team activities, ensuring compliance with PBW guidelines, EHS and GMP guidelines;
- Supervising updating documentation and / or project tracking tools as planned;
- Developing the main validation documentation (eg: protocol, report). Support the production of the master batch report and documents related to the validation of the DS manufacturing process for PBW;
- Reviewing and coordinating the delivery of input data to key documents and registrations for accuracy and completeness (where applicable);
- Participating in preparations for and in the inspections of pharmaceutical regulatory authorities;
- Coordinating the preparations for the production campaign (as part of the validation of the active substance manufacturing process);
- Participating in the development and updating of procedures and documentation templates as part of validation of manufacturing processes;
- Contributing to the optimization of DS manufacturing validation processes;
- Informing direct supervisor about all abnormalities in process, documentation, progress of tasks and decisions;
- Reporting the work progress and tasks status to supervisor;
- Reporting preparation of performed tasks;
- Cooperating with all groups from site and Polpharma Biologics group.
If you have:
- Higher education in the field: biotechnology, pharmacy or related;
- Min. 5 years of professional experience in the biotechnology or pharmaceutical/medical industry;
- Experience in validation of manufacturing processes and cleaning validation;
- Excellent knowledge of GMP, EMA and FDA requirements and current technology transfer guidelines;
- Practical knowledge of PV in pharmaceutical production;
- Very good command of the English language;
- The ability to organize work well and to cooperate in a team;
- Ability to identify and solve problems independently;
- Very good knowledge of MS Office.
What 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.