Process Support Specialist Co. Carlow
2 weeks ago
A new opportunity has arisen for a Process Support Specialist to join our clients busy pharmaceutical site in Co. Carlow.
Key Responsibilities- Generate and expedite review and approval processes for IPT GMP documentation, including Quality Notifications, CAPA close out records, IPT Standard Operating Procedures, and Standard Work Instructions and change controls.
- Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety, and reliable supply to customers.
- Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications.
- Be a document system expert, including document review, approval, and document system workflow expedition.
- Support operation activities through documentation generation, filing, tracking, auditing, and efficient maintenance of all associated databases.
- Raise CAPAs and conduct investigations, and implement subsequent corrective action through the change management system.
- Complete customer complaint investigations and change controls, and ensure they are closed out to support production activities in a timely manner.
- Bachelor's Degree or higher in a Science, Engineering, or other Technical discipline.
- SAP knowledge and experience required.
- Proficiency in Microsoft Office and job-related computer applications required.
- Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
- Report, standards, policy writing skills required.
- Equipment and process validation, sterile filling processes and equipment, and Lean Six Sigma Methodology experience desired.
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Process Support Specialist Co. Carlow
1 week ago
Pittsburgh, Pennsylvania, United States Pro Chem Inc. Full timeJob Title: Process Support Specialist Co. CarlowJob Summary:This is an exciting opportunity for a Process Support Specialist to join our team at Pro Chem Inc. in Co. Carlow. As a Process Support Specialist, you will be responsible for generating and expediting review and approval processes for IPT GMP documentation, including Quality Notifications, CAPA...
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Process Support Specialist Co. Carlow
2 weeks ago
Pittsburgh, Pennsylvania, United States Pro Chem Inc. Full timeJob SummaryA new opportunity has arisen for a Process Support Specialist to join our clients busy pharmaceutical site in Co. Carlow.Key ResponsibilitiesGenerate and expedite review and approval processes for IPT GMP documentation, including Quality Notifications, CAPA close out records, IPT Standard Operating Procedures, and Standard Work Instructions and...
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