#PolpharmaBiologics 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 medicine, offering new hope to patients suffering from serious diseases.
We create a passionate and friendly workplace environment. Join us!
WE ARE LOOKING FOR:
CSV Specialist
Duchnice (pow. warszawski zachodni)
WHAT MAKES US SPECIAL
- International work environment
- Attractive salary
- Cutting-edge technology equipment
- Conferences and trainings around the world
You will take care of:
- Authoring, reviewing and approving validation and qualification documentation and providing guidance to site staff on cGxP requirements for CSV;
- Initiating and performing the GxP risk and impact assessments;
- Taking part in CSV related Deviation, CAPA and change control management;
- Managing CSV status of technical systems, equipment and production installations;
- Conducting activities in accordance with the applicable cGMP, FDA CFR 21 Part 11, Annex 11 and internal procedures;
- Collaborating with QA, IT, Engineering, other business units, contractors and vendor resources to ensure successful planning, execution and delivery of validation projects and documentation deliverables;
- Computer System Validation Plan elaboration and management;
- Optimization of Computer System Validation process.
If you have:
- Higher directional education (Computer Science, Engineering or technical related fields);
- Possess working knowledge of global GxP regulations (21 CFR Part 11, Data Integrity, Annex 11 & GAMP5);
- Knowledge and understanding of latest industry data integrity trends, lifecycle management of computerized systems (e.g. alarm management, incident- and error management, periodic reviews);
- Minimum 3+ years of experience in computerized system validation within a regulated environment including performing a risk-based end to end systems validation;
- Ability to recognize and solve problems independently, good organization and presentation skills, ability to work efficiently under time pressure;
- Strong change control, gap, root cause analysis experience;
- Experience in creation/maintenance & implementation of SOPs;
- Must be well-organized and a team player;
- Must be detail oriented, with strong analytical and problem-solving skills, and to effectively research, troubleshoot, and solve challenging problems involving integrated systems;
- Fluent English;
Join our Team!
We offer
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Apply for the job
Contact us for details
Recruiter
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com