CSV Senior Specialist
Gdańsk
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:
- 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
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)
- 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
- Flexibility, communication skills, teamwork spirit