QA Validation Specialist
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!
Your responsibilities:
- Plan, managed, support and implement the quality assurance of process, cleaning, transport and sanitization/sterilization validation program consisting of entire system lifecycle in order to ensure compliance with relevant regulatory requirements and industry guidelines.
- Delivering the quality assurance of process, cleaning, transport and sanitization/sterilization processes through:
- Working with the User, ENG department and the Head of QA Validation to define and execute the programme of work to deliver compliant validation programme.
- Assisting with the development of system requirements and specifications to ensure that the requirements are testable and that the relevant regulatory requirements are met.
- Evaluating proposed strategy and/or proposed changes to validation program of process, cleaning, transport and sanitization/sterilization processes and recommending the level of validation activities required to ensure delivery of a robust, compliant validation programme meeting regulatory requirements and industry best standards, both in start-up and sustained operations.
- Ensuring initiation, review and closeout of all deviations, CAPA and change control TWD records related to process, cleaning, transport and sanitization/sterilization validation processes.
- Supporting Project Management of the validation campaigns incl. participation in contracting out activities.
- The role requires development of in-depth knowledge in the process, cleaning, transport and sanitization/sterilization validation processes and validation management through:
- Developing in-depth industry knowledge and following industry trends to ensure a high standard of the quality assurance in order to meet the relevant regulatory requirements.
- Continuous development through internal and external training as well as developing relevant knowledge in their own capacity.
- The role requires to be able to manage and accommodate change, be able to work with people and to be assertive to achieve the outcome.
- Additional areas of responsibility may be added as the role may develop along with the development of the organization.
If you have:
- University degree in a science/ engineering (biotechnology, biology, pharmacy or equivalent).
- Experience or willing to learn cleaning, transport and process validation.
- Fluency in spoken and written English.
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.