Production Manager

Galway

Basic Summary:

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.

Person Specification:

  • 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

Production Manager

Galway