Job Description
Our client is a highly ambitious young Biopharmaceutical company, seeking a strong self-starter experienced in setting up and maintaining QMS documentation processes.
Job Spec
Perform system administration tasks and Document Controller Role in the electronic document management system (eQMS) which manages all QMS controlled documents such as SOPs, Policies, Work Instructions, forms, templates, etc.
Liaise with document owners to manage QMS new and/or revised controlled documents through eQMS lifecycle including:
- formatting QMS documents to company defined formats
- managing review and approval process
- issuing QMS documents
- assigning training
- managing Periodic Review process
- managing document change control process
Ensure compliance with good documentation practices to ensure documents and processes process are GxP compliant.
Perform QA admin tasks to support the quality department including maintaining Quality related tracking logs such as
- Quality events (CAPAs, deviations, NCRs)
- Change Control
- Audits
- Vendor qualifications
Support inspection readiness activities.
Provide admin support to QMS improvement initiative and QMS development.
Support the maintenance of employees training matrix and records.
Person Spec
Proven work experience, at least 2 years, in a quality document control role preferably in pharmaceutical or medical device development.
Working knowledge of Electronic Document Management Systems (EDMS)
Hands-on experience with MS Office and MS Excel with proficient typing and editing skills
Excellent written communication and data organisation skills
Detail-oriented and able to demonstrate a high level of accuracy
Excellent communication, organisation and teamwork skills.
An understanding of ICH guidelines governing pharmaceutical drug development is strongly preferred.
For further information on this QMS Document Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: https://www.rftgroup.ie