This role is a 12 Month contract with a view to extension.
The IPT Process Support Specialist will report to the operations Coach ( Manufacturing Support) and be Responsible for generating and expediting review and approval processes for IPT GMP documentation including but not limited to Quality Notifications, CAPA close-out records, IPT Standard Operating Procedures, and Standard Work Instructions and change controls. 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 and Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.
• Comply with our 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 another Technical discipline.
• Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting.
• 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.
• Understand the specific responsibilities of all departments as they relate to one’s own.
• department, understanding the business processes one department supports.
• Strong team skills, including the ability to coach/develop work teams.
• Excellent training, facilitation, and assessment skills.
• Risk management skills.
• Strategy planning and development.
• Demonstrable analytical and systematic problem-solving skills.
• Strong influencing skills.
• Flexible approach.
• Effective time management and multi-tasking skills.
• Proven organizational skills.
• Excellent attention to detail.
• Troubleshooting skills.
• Goal/results orientated.
• Focus on Customers and Patients.
• Act with Candour and Courage.
• Make Rapid, Disciplined Decisions.
• Drive Results.
• Build Talent.
• Demonstrate Ethics and Integrity.
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