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
Essential:
• 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.
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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
