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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.

Position Summary:

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.

Primary 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.

Requirements:

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.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled