Contact: Niamh Hlubek
Telephone: 086 8168298
eLIMS Business Analyst - Contract
Our client, a pharmaceutical company in Cork are currently looking to recruit an eLIMS Business Analyst for their site on a contract basis.
- The eLIMS Business Analyst will be responsible for working with the eLIMS team in implementing eLIMS
- Representing QC in the eLIMS sub teams.
- Site Key User (SKU) and Single Point of Contact (SPOC) for eLIMS issues and escalation to global eLIMS team.
- Define QC eLIMS Reporting Requirements
- Developing Process maps for eLIMS
- Developing a training Plan and delivering training for eLIMS Users.
- Preparation of Local SOPS.
- Performing Qualification and/or change control on the systems.
- Configuration of Master / Static data
- Ownership of eLIMS Trackwise records such as investigations, CAPAs, Change controls etc.
- Partners with other Departments to ensure that activities related to QC are completed in an efficient manner.
- Organise and participate in meetings and conferences related to the global implementation of eLIMS
- Provide timely information to site management on the development and use of LIMS.
- Establish effective partnerships with other individuals, departments and affiliates so that QC activities are well understood and coordinated.
- Represent the company where appropriate in meetings and other communications with Global LIMS team.
- BS in a scientific/technical discipline required
- Related experience within the biological and/or pharmaceutical industry.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
- Experience in performing training and preparing SOPs
- Knowledge of LIMS
- Demonstrated knowledge and application of industry regulations as they apply to QC methods and procedures, including those of FDA, IMB, EMEA and other authorities.
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