Fastnet The Talent Group
Associate Director Change Control
The Change Control Lead is responsible for the effective and efficient running of all operations within the Change Control team and promoting a stable process supported by a flexible, collaborate, multi-skilled teamwork environment. Responsibilities. Governance of the Change Management process on site. Owner of the site Change Review Board meeting, ensuring changes are reviewed and concurred with site Leaders. Coaching the team of Change Control Specialists within the department as well as Change Owners from across the site. Liaise with Reg Affairs colleagues for changes requiring submission to Regulatory bodies. Build relationships with global colleagues to facilitate a streamlined change review and approval process. Development of area personnel and provision for succession & delivery of area performance to meet or exceed performance and quality goals. Participate and Comply with the Quality Management System (QMS) and Quality Systems Improvement Program (QSIP) requirements, including ownership, as relevant to you. Continuous improvement of systems & procedures on site, to ensure compliance with the most up to date cGMPs. Participate in inspections by Divisional Auditing Group and Regulatory Bodies Co-ordination of the area resources to deliver a quality and efficient. support service. Control of area expenditure within budgetary limits & Contribute to site management operational and strategic initiatives. Requirements. Degree or 3rd level qualification (Science, Quality. Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Quality, Science etc.) At least 5 years' experience in the Pharmaceutical industry or a similar operating environment which includes experience in a management / leadership role in a Quality or Regulatory Affairs function. Demonstrated experience of an IT based Change Control Platform. Front Line Inspection experience in Change Control. SME knowledge with writing and reviewing change control documentation. Knowledge of and experience in applying Lean Six Sigma and Lean methodologies. Knowledge and experience in interpreting current regulatory requirements and providing independent support to a manufacturing operation. Demonstrated leadership and change management skills with a continuous improvement focus. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on RecruitIreland.com.
104 days ago