Job Description
We are currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Carlow.
This is an excellent position for anyone looking to join a leading multinational who excel in their field.
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Duties
* Be a document system expert, responsible for document review, approval, and workflow expedition.
* Format, write, deliver, and review necessary documentation in line with the standard approval process.
* Facilitate others to do so by creating SOP's, SWI's, training documents, and change controls.
* Support operation activities through documentation generation, filing, tracking, auditing, and efficient maintenance of associated databases.
* Maintain, audit, and archive the process documentation system.
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Responsibilities
* Ensure timely completion of Quality Notifications.
* Generate Interim/Summary reports to meet batch release requirements.
* Raise CAPA's and conduct investigations using standard tools and methods.
* Resolve system issues through corrective action implementation via the change management system.
* Complete customer complaint investigations and Change Controls.
* Close out these items in a timely manner, supporting production activities in conjunction with the SCM team.
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Requirements
* Bachelor's Degree or higher preferred in Science, Engineering, or other Technical disciplines.
* SAP knowledge and experience required.
* Report, standards, policy writing skills required.
* Experience with equipment and process validation.
* Knowledge of sterile filling processes and equipment.
* Lean Six Sigma Methodology experience desired.
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Guidelines
Compliance with Merck Global Policies, Procedures, and Guidelines, as well as regulatory requirements and current Good Manufacturing Practices (cGMP), is essential for this role.