#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 Expert
Gdańsk Science & Technology Park, Trzy Lipy 3
WHAT MAKES US SPECIAL
- International work environment
- Attractive salary
- Cutting-edge technology equipment
- Conferences and trainings around the world
As Computerized Systems Validation Expert at Quality Compliance Department you will collaborate with Automation, IT, Engineering, other business units, contractors and vendor resources to ensure successful planning, execution and delivery of validation projects and documentation deliverables. It is an exciting opportunity to join the Compliance Department within a dynamic, fast moving environment and get experience in biotech industry.
You will also take care of:
- Serving as Subject Mater expert for GXP Software Qualification and Validation utilizing the Good Automated Manufacturing Practices (GAMP) life cycle methodology
- Authoring, reviewing and approving validation and qualification documentation and providing guidance to site staff on cGxP requirements for CSV
- Performing and approving the GxP risk and impact assessments
- Approving CSV related Deviation, CAPA and change control
- Conducting activities in accordance with the applicable cGMP, FDA CFR 21 Part 11, Annex 11 and internal procedures
If you have:
- Higher directional education (Computer Science, Engineering or technical related fields)
- 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 5+ years of experience in computerized system validation within a regulated environment including performing a risk-based end to end systems validation
- Strong change control and root cause analysis experience
- Experience in creation/maintenance & implementation of SOPs
- Experience in implementing SAP
- Ability to recognize and solve problems independently, good organization and presentation skills, ability to work efficiently under time pressure, team spirit
- Attention to details, with strong analytical and problem-solving skills, 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