Our client, a pharmaceutical company in Carlow are currently looking to recruit an Operations Team Lead for their site.
Take ownership for designated suite and others as required. Responsible for the operations teams, process equipment and all activities affecting them. Provide leadership, cross functional development and technical expertise to operations, maintenance and administrative personnel in the management of products. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers.
- Manage production related schedule adherence, tasks and resources in IPT and cross functionally; partner with colleagues to perform vendor management, communications, training, project work, audit/inspection duties etc.; thereby ensuring department is audit/inspection ready.
- Oversee operation and monitoring of production activities and support equipment, using MES/DCS and PLC based systems. Manage equipment flow, including tracking of soiled and clean hold times, proper labeling and inventory management of clean and sterile equipment using Kanbans and automated MES system to set QC status and expiry of sterile equipment. Ensure clean room cleaning, housekeeping and materials management in all production areas are completed to standard, whilst driving continuous process improvements using Lean Principles, to ensure optimum equipment uptime and target outputs.
- Oversee maintenance of process equipment, ensuring ongoing preventative maintenance, equipment troubleshooting and repairs to ensure continuous, reliable and repeatable operation of all equipment specifically in their suite. Ensure effective management and equipment shutdown scheduling, ensuring resources are available, thereby minimizing downtown.
- Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various IPT systems; ensure all work is subsequently carried out in line with same.
- Ensure equipment reliability and performance by facilitating effective systems for identification of root cause failures, recommendations and implementation of improvement changes throughout processes, ensuring calibrations of equipment are performed as necessary. Drive continuous improvement by leading and active participation in system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Manage root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 whys etc.; oversee and implement subsequent corrective action through the change management system.
- Drive compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions
- Leadership activities including selection, development, coaching and day to day management.
- Ensure that the team receives appropriate resources and programmes to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programmes.
- Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
- Third level degree in a Science/Engineering related discipline or equivalent required
- Considerable experience in the Pharmaceutical or Manufacturing industry. Strong interpersonal and communication skills and strong understanding of Pharmaceutical GMP systems are essential. Knowledge of Aseptic Manufacturing and experience in Front Line Management is essential
- Sterile filling processes and equipment
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Report, standards, policy writing skills required
- Proficiency in Microsoft Office and job related computer applications required
- Lean Six Sigma Methodology experience desired
- Excellent communication, presentation and interpersonal skills, to interface
- effectively with all levels of colleagues and with external customers in a team orientated manner
- Understand the specific responsibilities of all Carlow departments as they relate to one?s own department, understanding the business processes ones department supports
- Progressive people management skills
- Excellent facilitation and assessment skills
- Customer service
- Vendor liaison
- Flexible approach
- Effective time management and multi-tasking skills
- Excellent attention to detail
- Trouble shooting skills
- Goal/results orientated
- Data analysis
- Strong change management skills
- Effective conflict resolution skills
- Negotiation skills
- Demonstrable analytical and systematic problem solving skills
- Strong influencing skills
- Business acumen
- Strategy development
- Risk management skills
- Ability to effectively manage complex projects across multiple disciplines
- Proven financial management skills
- Focus on Customers and Patients
- Act with Candor and Courage
- Make Rapid, Disciplined Decisions
- Drive Results
- Build Talent
- Demonstrate Ethics and Integrity
For further information on this Operations Team Lead role in Carlow please contact Anna McGowan on 091730022/0864667369 or email firstname.lastname@example.org
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