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Aktualne oferty pracodawcyCSV Specialist
Polpharma Biologics
- Trzy Lipy 3, GdańskGdańsk, Pomeranian
- offer expired 16 days ago
- contract of employment
- full-time
- specialist (Mid / Regular), senior specialist (Senior)
- full office work, hybrid work
- remote recruitment
Polpharma Biologics
Trzy Lipy 3
Gdańsk
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
Our requirements
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 2+ 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
What we offer
Private healthcare;
Life insurance;
Pension plan above national standards;
Relocation package;
Additional free day;
and more…
Benefits
private medical care
life insurance
remote work opportunities
flexible working time
fruits
retirement pension plan
coffee / tea
extra social benefits
pre-paid cards
redeployment package
employee referral program
charity initiatives
extra leave
Polpharma Biologics
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!