19677 – Quality Specialist – Carlow Contractor

This is a 12 month contract with a view to extension

Purpose

The Quality Specialist supports the design and qualification of the facility as well as the introduction and execution of product technical transfer to the Project facility. Ensure compliance with Global, capital project & regulatory guidelines. Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to our customers

Responsibilities

 Comply with Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions
 Work collaboratively to drive a safe and compliant culture in Carlow
 Perform quality function in Quality Risk Assessments
 Review and Approve system design documentation in area(s) of responsibility from a Quality perspective
 Pre and Post Approve C & Q test documentation in area(s) of responsibility
 Review and Approve validation summary reports supporting qualification
 Ensure compliance to project C&Q leveraging strategy.
 Complete all assigned training in a timely manner
 Provide Quality support to offsite testing activities (FAT) as required.
 Perform Quality function on all project change controls
 Represent and fulfil the quality function at suite team meetings as required per area(s) of responsibility
 Support the introduction of new products onto site in relation to Quality oversight, covering the end to end strategy.
 Authors, reviews and participates in approvals of protocols and reports for technology transfer.
 Review other documentation associated with new product introduction (QC Test Specifications, BOMs, MES documentation etc.)
 Attend and participate in Quality team meetings as required

Requirements

 Bachelors Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
 Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
 Knowledge of cGMP and GDP
 Knowledge of Pharmaceutical manufacturing processes Report, standards, policy writing skills required
 Equipment and process validation
 Sterile filling processes and equipment
 Proficiency in Microsoft Office and job related computer applications required
 Lean Six Sigma Methodology experience desired