We’re 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 known for excellence in the field.
Duties
* Become a document system expert; responsibilities include document review, approval, and workflow management. Format, write, deliver, and review documentation aligned with standard approval processes. Documents include SOPs, SWIs, training materials, and change controls.
* Support operational activities through documentation generation, filing, tracking, auditing, and maintaining databases, including archiving of process documentation systems.
* Assist in batch release processes by completing Quality Notifications timely, generating interim/summary reports, and ensuring batch release requirements are met.
* Raise CAPAs and conduct investigations using standard tools like FMEA, Fishbone diagrams, and 5 Whys. Implement corrective actions via the change management system.
* Handle customer complaint investigations and change controls, ensuring timely closure to support production activities in collaboration with the SCM team.
* Ensure compliance with Merck Global Policies, Procedures, Guidelines, regulatory requirements, and cGMP in daily activities and all related functions.
Education & Experience
* Bachelor’s Degree or higher, preferably in Science, Engineering, or a related technical field.
* Experience with SAP is required.
* Skills in report writing, standards, and policy development are necessary.
* Experience with equipment and process validation.
* Knowledge of sterile filling processes and equipment.
* Lean Six Sigma experience is desirable.
If interested, please contact Seán McCarthy at +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.
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