Life changing therapies.
Global impact.
Bridge to thousands of biopharma companies and their patients.We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow.
Our strategy includes building teams across our global network to pioneer and shape the future of PCI.Summary of Role:The role will assume responsibility for all operational aspects of their production shift inclusive of H&S, GMP compliance, line productivity, resourcing allocation / training and housekeeping.
Requires a proactive drive towards continuous improvement and efficiencies while ensuring customer expectations are met on a continuous basis.Responsibilities: • Manage the performance of the production shift ensuring compliance with H&S, GMP, Customer Requirements and PCI Policies & Procedures.• Ensure the production area is maintained in an audit ready state for both customer and regulatory inspections and act as SME for all visits.• Work with the Planning, Warehouse & QA teams to ensure production kits are available OTIF.• Ensure clear and accurate communication of current production status to all relevant departments through the necessary meetings / updates.• Ensure all batch components are reconciled / dispositioned correctly and in a timely manner.• Manage shift deviations and quality issues through to validation of corrective and preventive actions ensuring investigations are closed out in a timely manner.• Work with the Continuous Improvement team and Department Managers to deliver operational excellence within PCI Ireland focusing on the production function.
• Work with the NPI / Validation functions to ensure projects are completed on schedule.• Ensure shift KPI's are maintained and updated with appropriate corrective actions to rectify downward trends / out-of-spec results• Identify resourcing and training deficits, working with the Operations Manager to develop and implement a plan to correct in a timely and appropriate manner.Knowledge / Skills & ExperienceEssential:• Minimum of 3 years' experience in a pharmaceutical, medical device or similar environment.• 3rd level diploma or degree in related discipline with comprehensive knowledge of GMP / regulated environment.• Familiar with ERP system management and usage.Desirable: • Dynamic, lead-by-example hands-on individual prepared to take responsibility.
• High level of PC skills required.• Pragmatic leadership approach with demonstrated ability to coach and mentor team members.• Excellent analytical and critical thinking skills with a record of successfully change management.• Excellent communication and interpersonal skills, both verbal and written.#LI-MS1Join us and be part of building the bridge between life changing therapies and patients.