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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 & Experience
• 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.
• 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.
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Join us and be part of building the bridge between life changing therapies and patients.
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