This is a 12 Month Contract with a view to extension
• Responsible for generating and expediting review and approval processes for IPT GMP documentation including but not limited to Quality Notifications, CAPA closeout records, IPT Standard Operating Procedures, and Standard Work Instructions and changes control. Ensure that objectives are effectively achieved and consistent with The Company’s requirements to ensure compliance, safety, and reliable supply to our customers.
• Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities, and completion of quality notifications. Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT
• Be a document system expert; this will include document review, approval, and document system workflow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOPs, SWIs, training documents, and change controls. Support operation activities through documentation generation, filing, tracking, auditing, and efficient maintenance of all associated databases including the maintenance, auditing, and archiving of the process documentation system.
• Support Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.
• Raise CAPAs and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s, etc.; implement subsequent corrective action through the change management system.
• Complete Customer complaint investigations, Change Controls and ensure they are closed out to support production activities promptly in conjunction with the SCM team.
• Required to comply with The Company’s Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Work collaboratively to drive a safe and compliant culture.
• May be required to perform other duties as assigned
• Assist in the management and/or assignment of IPT training if required
• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering, or other technical disciplines
• SAP knowledge and experience required
• Proficiency in Microsoft Office and job-related computer applications required
• Knowledge of regulatory/code requirements for Irish, European and International Codes, Standards, and Practices
• Report, standards, and policy writing skills required
• Equipment and process validation
• Sterile filling processes and equipment
• Lean Six Sigma Methodology experience desired
• Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team-orientated manner
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