This is an 11 month contract
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, consistent with the companys 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 work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP’s, SWI’s, 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 CAPA’s 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.
• Required to comply with Merck 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 in Carlow.
• 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 discipline.
• SAP knowledge and a minimum of 5+ years’ experience required.
• Proficiency in Microsoft Office and job-related computer applications required.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report, standards, 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 Carlow departments as they relate to ones own department, understanding the business processes ones department supports.
• Strong team skills, including ability to coach/develop work teams.
• Excellent training, facilitation and assessment skills.
• Strong influencing skills.
Must be available and flexible to work shifts 24/7 – day, nights and weekends.
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