#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:
Computerized Systems Validation 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
You will take care of:
- Serving as Subject Matter Expert for GxP software Qualification and Validation utilizing the Good Automated Manufacturing Practices (GAMP) life cycle methodology
- Authoring, reviewing and approval of validation and qualification documentation and providing guidance to site staff on cGxP requirements for CSV
- Authoring, reviewing and approval of computer system validation deliverables and presenting them to QA for approval
- Initiating and leading the GxP risk and impact assessments
- CSV related Deviation, CAPA and change control management
- Overseeing the 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
- Taking a leadership role and ownership of project related tasks, work under minimal supervision
- Collaboration with QA, IT, Engineering, other business units, contractors and vendor resources to ensure successful planning, execution and delivery of validation projects and documentation deliverables
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 7+ years of experience in computerized system validation within a regulated environment including leading 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
- Fluent English
- Flexibility, communication skills, teamwork spirit
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