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.