Description
My client, a leading pharmaceutical organisation based in Waterford is seeking a Validation Engineer for a 6 month contract to start within the next month.This is an exciting 6 month hourly rate contract opportunity with potential for a further 6 month extension.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
*To Contribute on the preparation and review of the Validation Master Plan
*To manage the preparation, review and issuing of Validation Protocols and Reports (this to include equipment, cleaning, process and computer system validation)
*To develop, maintain and take responsibility for the cleaning validation strategy
*To assume responsibility for the cleaning validation master plan confirming to accepted practices and demands of the competent authorities in the EU
*Implementation of Process Validation of new products
*Coordination of the execution of Validation in accordance with protocols by Production, Quality Control and R&D teams
*Establishing, implementing and directing validation and revalidation activities
*Liaise with contract manufacture customers in seeking their approval for protocols and reports where appropriate
*Manage the validation requirements and third party suppliers and CMO's
*Reviewing and managing Change Control Forms for Validation/Compliance implications
*Conduct Routine Internal Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise.
*Updating existing quality documentation related to validation activities
*Identifying training requirements in support of validation
*Ensuring completion of validation protocols
*Maintaining validation documentation system
*Perform Product Quality Review ensuring timely completion of PQRs and adherence to schedule and GMP requirements.
*Liaising with customers as the need arises
*Assist in the maintenance/co-ordination of the core Quality Systems
*Assist in the investigation of Customer Complaints as required.
*Review/lead Process investigations and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.
*Contributing to the overall improvement of the company from a Quality/GMP perspective with an emphasis on continuous improvement of the quality system.
*Any other duties as assigned by the Head of Quality/Technical Manager.
REQUIREMENTS
*Bachelor's degree in Science, Engineering, Technology or a related discipline.
*Experience working within a Pharmaceutical Manufacturing Environment.
*Industry knowledge of the requirements of EU GMP (IMB/FDA).
*Experience and knowledge of solid oral dosage processes would be an advantage.
*Excellent organisational / time management skills.
If you are interested in this role please contact Derek Sheridan on or submit your CV ASAP to be considered for interview!
To find out more about Real please visit www.realstaffing.com