·The Quality Control Director will manage and lead the site QC team aligned to the site strategy and volume requirements
·Ensure Provision of QC GMP subject matter expertise and consultation points of contact to partner lines both inside and outside the site to ensure compliance by providing an independent QC check to the site regarding the product control, advising of early trends and issues noted in the product in order to take adequate measures.
·Ensure Provision of the Quality Control release function in line with EU directives, site procedures and regulatory authorizations and act as SME/QC lead in HA audits
·Sets the overall direction of the analytical work conducted within the team in the QC laboratory aligned with budgeted volumes and resourced adequately.
·Accountable for the quality of overall data output from the Quality Control laboratory.
·To take appropriate compliant action with respect to any discrepancies, deviations or non-conformance’s in testing or work practice
·To ensure that good housekeeping, hygiene and GMP standards are maintained in the laboratory by inspection, training, review and audit.
·Responsibility for compliance of the QC laboratory to EU/ FDA standards.
·To ensure that the maintenance program for lab equipment and IT support systems is current and aligned to HA and Budget requirements.
·To ensure the smooth and compliant transfer of analytical methodologies in to the commercial Quality control laboratory where appropriate and required
·To ensure Managers and Supervisors are adequately in control of schedules and short, medium and long term schedules align with S&OP requirements
·To ensure growth and development by mentoring and coaching of staff with the Quality Control teams.
·To embed a culture of continuous improvement and compliance in the QC area
·Minimum of a third level qualification in Chemistry or related discipline
·At least 10 years technical experience in a highly regulated laboratory environment (HPRA/FDA)
·Demonstrated management experience in a laboratory environment
·An understanding of Lean Principles/Operational Excellence tools and "hands on" implementation of same in a QC lab is a requirement
·Strong organisational skills with the ability to multitask and prioritise workload in a fast moving environment
·Be capable of initiating and managing operational improvements
·Have the ability to influence effectively whilst leading, managing, motivating a team and delivering results through people
·This job will require excellent verbal, written and interpersonal communication skills with the ability to interact effectively at all levels within the organisation
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