Sterile Ops Team Leader
Overall Purpose: The Sterile Operations Team Leader is responsible for day to day operations in product compounding and sterile fill & finish. The successful candidate will lead a team of manufacturing team members. The Sterile Operations Team Leader will help design the manufacturing and supporting processes required to build a safe working environment that delivers best in class performance in Quality, Delivery & Cost. This successful candidate will have the opportunity to recruit, train and develop the team that will support the site through qualification and validation activity and subsequently into commercial operations. Aerie intends to build teams and ways of working that are based on lean principles designed to ensure the site embeds a strong Quality Excellence culture. The Sterile Operations Team Leader will have the opportunity to help build these systems of work and that Quality Excellence culture. Essential Duties, Functions and Responsibilities: Work with site colleagues as part of an Operations team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site. Prioritise safety and is diligent in the use of all appropriate safety tools and permits when at work – champions safe working always both personally and with the team. Ensure a Quality Excellence mindset at all time, where every team member aims to ‘do the right thing’ and fosters a culture where team members feel confident to raise quality concerns or to highlight mistakes or risks. Work with technical colleagues to build robust area and operational standards and ways of working. Ensure strong and focused execution of manufacturing activity against these standards. Is therefore a champion of lean ways of working in manufacturing. Plan and oversee manufacturing activities and resource allocation to ensure delivery of production schedules. Own, monitor, communicate and review manufacturing area KPls across Safety, Quality, Delivery and Cost to ensure the team delivers the highest levels of performance. Responsible for manufacturing area house keeping and ensuring full compliance with site 5S systems. Take ownership of environmental performance in the manufacturing area and work continuously to ensure the strongest environmental performance possible by proactively and constantly improving control strategies and employee engagement in this area. Encourage and foster continuous improvement in manufacturing as fundamental to Quality and Operational Excellence. Oversee the design, maintenance, completion and review of production documentation to build a documentation culture of right first time document completion and to minimise the risk of human error in documentation design. Supports Quality colleagues (QA and QP) in their review of batch documentation to ensure timely release of products from site. Manufacturing subject matter expert during regulatory audits and maintain an “Always Audit Ready” mindset in manufacturing areas. Lead and support investigations in manufacturing or technical deviations. Lead and develop team members to ensure strong individual and team performance and to ensure all have development plans that support their personal professional development. Effectively communicate with the team on team and site information. Ensure staff training and development is comprehensive to ensure staff are always fully trained to complete their manufacturing tasks and are constantly being developed. Ensure manufacturing team members are trained and confident to work with computerised systems including ERP, MES and Quality IT systems and ensure highest levels of GMP data integrity. Supports product or process development projects and associated validation activities. Skills/Knowledge Required: Excellent knowledge of aseptic manufacturing techniques and procedures. Experience working with equipment automation systems required to operate these systems. Experience developing and using manufacturing batch records, SOPs, etc. Familiar with lean systems of work including 5S, structured problem solving, KPI management, standard work, etc. Strong communication and interpersonal skills. Highly motivated with ability to lead effectively while working cross functionally with other Aerie colleagues. Good proactive approach & manner. Education Required : Bachelor degree in Engineering/Science/Manufacturing or equivalent. Certificate or Diploma Qualification in GMP and/or in manufacturing leadership would be a distinct advantage. Experience Required: At least 8 years’ experience in a sterile fill and finish pharmaceutical manufacturing operations. 3+ years experience as a supervisor/team leader in the pharmaceutical industry. Demonstrated track record of fostering a continuous improvement environment and in the training and development of manufacturing personnel. Applicants should email their cv to firstname.lastname@example.org or call me on 01-9476227 for a confidential conversation. This job originally appeared on RecruitIreland.com.
104 days ago