Quality Documentation Controller

Cookie NoticeQuality Documentation Controller page is loaded## Quality Documentation Controllerlocations: Dublintime type: Part timeposted on: Posted Yesterdayjob requisition id: R-19498**Title:**Quality Documentation Controller**Company:**Ipsen Manufacturing Ireland Ltd**About Ipsen:**Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience.
Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries.
We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact.
At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success.
Join us on our journey towards sustainable growth, creating real impact on patients and society
For more information, visit us at and follow our latest news on and .
**Job Description:****WHAT -** **Summary & Purpose of the Position**The **Quality Document Controller** is responsible for supporting the documentation requirements of the Quality department at IMIL and performing Document management activities in the Easidoc Documentation management system.
**This position is available on a 12-month fixed term basis, working 30hrs per week.
****WHAT -** **Main Responsibilities & Technical Competencies*** Administration Management of the Easidoc system: System access, distribution groups, document workflows management , file purging* Preparation, distribution and storage of all company documentation that pertain to company compliance with cGMP.
Maintain and update the Easidoc electronic documentation system for cGMP documentation.
Issue new and revised documentation efficiently and ensure that documentation change is managed according to cGMP* Site Technical Expert for Easidoc; Documentation Manager Role, deputy system owner.
Perform DocManager tasks in EasiDoc to ensure that revisions to procedures progress through to activation in an efficient manner* Delivery of site wide training for Easidoc* Issue and reconcile documentation change control requests ensuring that document change is managed according to cGMP* Administration Management of specific batch record related data in support of Annual Product Reviews* Administration Management (preparation, issuance and reconciliation) of all related Production Batch documentation in accordance with the production schedule* Participation during site Internal Audit Programme and area walk downs* Administration Management (preparation, review and communication) of departmental, site and Corporate KPl's* Administration Management of employee/contractor GMP Training Records* Participation in departmental operational excellence initiatives* Administration Management Support to the Quality Group**HOW - Knowledge & Experience**Knowledge & Experience (essential):* 2 vears administrative experience within an office environmentKnowledge & Experience (preferred):* 3-5 years administrative experience within an office environment with experience working with electronic systems for document managementEducation / Certifications (essential):* Second Level Education, Leaving Cert or equivalentLanguage(s) (essential):* EnglishIPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.
### Get In TouchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.
#J-18808-Ljbffr