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Temporary IPC Analyst - Ireland  

Company managed [?] Still accepting applications

Posted on : 20 May 2017

Project Description

Description
  • Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.   
  • Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
  • Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.  
  • To this end, we strive to create an environment of mutual respect, encouragement and teamwork.  
  • As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


IPC Analyst
The IPC Specialist will provide IPC support within manufacturing operations and drive compliance within the IPT.



Activities Within Role
  • The team working style is one of collaboration, coaching and facilitating to provide compliance solutions to the IPT team to support a High Performance Organisation.
  • This position is accountable for the smooth execution of all appropriate functions associated within the IPT.
  • He/She will contribute to the High Performance culture within the IPT providing a flexible, accurate service to enable the department to achieve MMD four key priorities.  He/She is an active member of the IPT team providing support, guidance and expertise.
  • The IPC Specialist will participate and comply with the MMD Quality Management System (QMS) requirements, including ownership, as relevant to you.



Primary Activities/Responsibilities:

The following are examples of the activities required within the role, whereby the person must be flexible to perform all of the following functions and other tasks as needed:
  • Performing the IPC function: In-Process Testing; batch specific environmental monitoring
  • Documentation review.
  • Perform the investigation process, real-time investigation, SME input, etc.
  • Support ongoing compliance initiatives and projects such as Aseptic Excellence, RFT, Merck Quality Standards and Quality Management Systems, APMS etc.
  • Provide ongoing coaching and support to the cross functional team members, to share their technical knowledge and promote best practices.
  • Perform departmental preparation and close out for GMP and EHS audits.
  • Participate in cross functional teams to ensure IPT and site goals are achieved
  • Ensure highest Quality & Compliance standards
  • Ensure compliance with cGMP and other business compliance regulation
  • Preparation of procedural and change control documentation
  • Participate in cross functional teams to ensure IPT and site goals are achieved
  • Set-up and prepare equipment for ongoing operations;
  • Operate various computer controlled process support/process equipment (i.e. equipment control systems, DCSs, autoclave, Incubator, pH meters, washer, lyophiliser, cap/inspect machine etc (this list is not exhaustive);



Continuous Improvements:
  • Support and implement Kaizen/LSS Projects. 
  • Lead Continuous Improvement initiatives using Merck Sigma toolkit.
  • Coaching and Training:
  • Share knowledge and experience and coach others by sharing skill set and expertise.


Reports to:
Operations Lead

    
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