Job Description

Job Purpose:

Generating and expediting review and approval processes for IPT GMP documentation including Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls.

Responsibilities:

• 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
• Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases
• 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
• Work collaboratively to drive a safe and compliant culture in Carlow.

Skills and Knowledge:

• Currently pursing Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
• Proficiency in Microsoft Office and job related computer applications required
• Excellent communication, presentation and interpersonal skills, to interface effectively with levels of colleagues and with external customers in a team orientated manner
• Excellent attention to detail

PQ20

Required Skills:

Preferred Skills:

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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