Documentation Coordinator

Ref. no.: JO-1201-2406710

Tags: Cork Pharmacuetical Validation Quality Assurance Documentation Quality Cleaning Validatoin

Location(s): Cork

Salary range (€): Negotiable

Additional benefits:

Minimum experience required: No minimum required

Employment type: Contract

Minimum qualification: Third Level Degree

Contact person: Rory Walsh

Contact e-mail: Rory.walsh@cpl.ie

Job description:
CPL Cork has been retained by one of their key clients to partner in the sourcing and selection of Documentation Coordinator

Duties and responsibilities:
• Tracking and completion of change controls, deviations and CAPAs within the required timeframes to support the requirements of the Operations department and the site metrics.
• Preparation and processing of the relevant Operations documentation i.e. SOP's/WI's/Procedures, etc through the required systems
• Delivery of training modules and assessment/evaluation of trainees required to support completion of change controls, deviations and CAPA.
• Co-ordinate with the following key personnel: Quality Control, Cleaning Validation, Operations, Quality Assurance, Maintenance as required.
• Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
• Schedule, manage and Co-Ordinate the cleaning of Operations equipment for Tox/Clinical/ Commercial production
• Schedule, manage and Co-Ordinate Operation of washers/COP booths/CIP skids to clean and release equipment
• Schedule, manage and Co-Ordinate the samples and documentation required for equipment release
• Stream lining of cleaning verifications systems currently in place.
• Generation and review of documentation using eDoc and tracking of documents through approval cycle.
• Support investigation and resolution of documentation and other issues on plant.
• Delivery of training modules and assessment/evaluation of trainees.
• Review and preparation of training documentation (e.g. evaluation/assessment forms).
• Travel to other external sites for training as required.
• Ensure that personal training requirements are completed in compliance with site procedures.

Candidate Requiremants;
• Third level qualification in science, engineering, quality or other relevant discipline.
• Knowledge of FDA/EMEA regulatory requirements.
• Knowledge of cleaning validation and its regulatory requirements
• Experience of SAP and/or other business systems.
• Experience of eDoc, Documentum or other similar documentation management systems.
• Experience of training management systems.

If you are interested in hearing more about this opportunity, please call Rory Walsh, Senior Recruitment Consultant, for a confidential discussion on 021 4626112, or send your cv to rory.walsh@cpl.ie .

If you are not interested in this role but you would like to hear about future opportunities in the Pharmaceutical and Biotechnology Industries in Munster, please feel free to send your cv to rory.walsh@cpl.ie .

I will look forward to hearing from you.