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!
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:
- Shaping IT QMS processes in Polpharma Biologics Gdansk and cooperate within global organization for processes harmonization;
- Preparing review and consult IT systems Validation Documentation through entire systems lifecycle in Polpharma Biologics;
- Driving initial Validation approach and key activities for projects in Digitalization program;
- Supporting 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;
- Experience in automation and IT projects management);
- 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.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;
- Fluent English;
- Flexibility, communication skills, teamwork spirit.
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.