LSC have a requirement for a Senior Documentation Coordinator to join a leading biotech company based in Cork for a 12 month contract.
Reporting to the Documentation Team Lead, you will be responsible for:
Supporting the documentation strategy for all disciplines to ensure business, engineering, quality and compliance goals are met for the project, while adhering to GEP’s and GMP’s.
Administration and support of the relevant electronic document management systems (EDMS)
Coordination of documentation activities on the project:
-Coordinates review and approval workflows for engineering and project documentation
-Responsible for drawing repositories, engineering documentation, vendor documentation.
-Tracks documents through these processes and gives support to relevant users accordingly.
-Update Document Matrices/Registers for the project as required.
-Hardcopy management of updates to project documentation.
-Develops and applies project procedures in line with cGMPs and GEPs.
-Manages, prepares and catalogues documents for archival and retrieval when required.
-Supports all areas of the business during audit situations.
-Coordinates with internal and external stakeholders such as external vendors in relation to turnover of project documentation.
Other Skills, Experience and Education:
-Degree in Science or Engineering related discipline desirable, but not essential
-MBO level in a technical study.
-cGXP, SAP, and EDMS experience.
-Ability to partner and deliver results in a matrix environment.
-Influencing skills and strong project management skills.
-Certified as System Operator for the electronic document management System.
-At least 2 years experience in a similar environment as documentation specialist.
-Experience with EDMS.
Call Evelyn at LSC on 021 4777329 for more information on this new Senior Documentation Coordinator role, or apply directly via this advert.