"Praca IT Quality CSV Expert Polpharma Biologics / Praca Gdańsk"

Ta oferta pracy została opublikowana ponad 40 dni temu i może być nieaktualna.

kandydatów

IT Quality CSV Expert

Firma: Polpharma Biologics miejsce pracy: Gdańsk

IT Quality CSV Expert

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!

Your responsibilities

Shape IT QMS processes in Polpharma Biologics Gdansk and cooperate within global organization for processes harmonization
Prepare, review and consult IT systems Validation Documentation through entire systems lifecycle in Polpharma Biologics
Drive initial Validation approach and key activities for projects in Digitalization program
Support GxP IT systems’ design and modifications within investment projects; plan & execute appropriate actions to keep GxP compliance in control
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 IT related Deviation, CAPA and change control management
Conducting activities in accordance with the applicable cGMP, FDA CFR 21 Part 11, Annex 11 and internal procedures
Collaborating with QA, Engineering, other business units, contractors and vendor resources to ensure successful planning, execution and delivery of validation projects and documentation deliverables

If you have

Experience in designing and managing computerized systems in regulated environment
Minimum 2+ years of experience in computerized system validation within a regulated environment including performing a risk based end to end systems validation
Experience in IT projects
Experience in creation/maintenance & implementation of SOPs
Strong change control, gap, root cause analysis experience
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.incident- and error management , periodic reviews)
Ability to recognize and solve problems independently, good organization and presentation skills, ability to work efficiently under time pressure
Must be well-organized and a team player
Fluent English
Flexibility, communication skills, teamwork spirit
Nice to have higher directional education (Computer Science, Engineering or technical related fields)