The Production Manager is a pivotal position within Realoch Pharma and the role holder is responsible for the leadership of the daily production operation ensuring that a quality product is produced in a safe and cost-effective manner that meets our customer’s expectation and regulatory requirements
Essential Duties and Responsibilities:
- Management of the new start-up facility to full commercial manufacture.
- Work with Engineering, R+D, Quality, Product Launch and all relevant teams to ensure site qualification and validation is conducted successfully.
- Work with Registration and Quality Departments on the compilation of data required for EU and US product dossier submissions.
- Together with all departments, prepare and host customer, non-EU, EU and US authority inspections to ensure facility approvals are obtained and maintained.
- Successfully launch new products to full commercial manufacture.
- Overall management of day to day activities within production ensuring customer requirements are met in a timely, compliant, safe and cost-effective manner.
- Directly manage the Operations Team responsible for manufacturing product to targeted production plans in a quality driven manner.
- Ensure all operational performance measures are reached which include productivity, efficiency, waste, quality and safety. Prepare reports and present on same.
- Support site business strategies ensuring personnel are organized on appropriate shift patterns as required to ensure optimum operational performance is achieved.
- Manage and drive performance through the operations team and liaise with all relevant department managers on issues that directly affect the production activities.
- Drive a consistent team based approach across production ensuring open two way communication at all times. Drive team meetings, team problem solving, continuous improvement initiatives across the production department.
- Develop and maintain safety programs including appropriate training and communication sessions and ensuring the safety of all personnel.
- Manage people issues including absenteeism, return to work interviews, performance, management etc. in consultation with HR.
- Ensuring hygiene and housekeeping standards are at a level to ensure 100% daily GMP compliance. Identifying corrective action if GMP is not fully in compliance. Maintain the company QMS.
- Management of production budget
- Work closely with relevant managers to ensure appropriate assessment, staffing and scheduling of R&D projects and Product Launch Projects to ensure internal project milestones and customer expectations are assured.
- Work closely with Quality, Warehouse, Procurement and Engineering supervisors to ensure that production & shipping targets are met through open communications and teamwork.
- Resolve any non-conformance in the manufacturing system by timely and effective corrective action.
- Set KPI’s for direct reports and monitor performance against these goals.
- Champion Operational Excellence programmes and participate in projects as required
- Ensure that training records are maintained and a training plan prepared for each member of the production department.
- Ensure equipment is maintained in an acceptable condition such that product quality, personnel safety or the environment are not adversely affected.
- 5 years+ experience in a manufacturing management role, with a min of 3 years in the pharmaceutical industry. Experience in start-up project would be advantageous
- US FDA experience.
- Strong interpersonal skills, an innate ability to influence and build relationships at all levels and a driving vision to create an inclusive culture of performance, continuous improvement and development
- Have a high level of commercial and business awareness, be action oriented complemented by the resilience to achieve challenging objectives.
- Ability to challenge the views of others in a constructive and convincing manner where it is required to bring about positive change.
- Must be a pro-active self-starter and an excellent communicator with exceptional problem solving skills.
- Inspirational, able to influence, motivate and encourage teamwork
- Strong computer skills in MS Office and a knowledge of enterprise systems i.e. SAP