Job Opportunity with a Pharmaceutical Organization
We are seeking an experienced professional to join our team in Carlow, working for a leading multinational pharmaceutical company.
Duties:
* Document System Expertise: Review, approve and facilitate the document workflow process. Format, write and deliver necessary documentation according to standard approval processes.
* Support Operations: Generate documentation, file, track, audit and maintain associated databases, ensuring efficient maintenance of the process documentation system.
* Batch Release Support: Complete timely Quality Notification completion, generate interim/summary reports, meeting batch release requirements.
* Raise CAPA's and Conduct Investigations: Investigate quality notifications using standard tools and methods, resolve system issues and implement corrective action through the change management system.
* Customer Complaint Investigations and Change Controls: Ensure timely closure of investigations and changes to support production activities in conjunction with the SCM team.
* Compliance with Merck Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP).
Requirements:
* Bachelor's Degree or higher in a Science, Engineering or Technical discipline.
* SAP knowledge and experience required.
* Report, standards, policy writing skills required.
* Equipment and process validation.
* Sterile filling processes and equipment.
* Lean Six Sigma Methodology experience desired.