Materials Review Board (MRB) Technical Specialist (P2) Job

Date: May 22, 2019

Location: Cork, IE

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Requisition ID: ENG004428


MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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.
 

The Materials Review Board Technical Specialist will become a key team member of the newly formed Material Review Board Team within the Technology Center of Excellence Department which provides technical expertise to a growing site with an expanding portfolio of technologies and products.The successful candidate will work in a dynamic environment with exciting career opportunities. 

The Materials Review Board Technical Specialist will deliver on timley implementations of Supplier change notifications by conducting detailed technical assessments of the change , while working collobrative with all internal departments and external partners, to meet the our Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan 

The Materials Review Board Technical Specialist is responsible for actively participating in the Tier process to manage supplier changes and proactively manage and resolve issues before they impact the business priorities.

The Materials Review Board Technical Specialist will model the MSD Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation.

The Supplier Change Control Specialist will participate and comply with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant to you.


Primary activities/responsibilities:

  • Be the main point of contact within the team for Supplier changes assigned to them and to to ensure that key stakeholders are kept informed throughout the change control lifecycle process and that both internal & external expectations are managed.
  • To lead the full and detailed assessment of the impact of the proposed Supplier change(s) from a Safety, Quality, Technical and Supply perspective with the appropriate support from internal departments 
  • All necessary internal check are performed and that the identified tasks are fully completed before the Supplier proposed change is approved whilst ensuring adherence to internal change control procedures.
  • Coordinate and priortise multiple Supplier change controls notifications to ensure they are delivered in a timely fashion while ensuring the highest Quality & Complicance standards throughout the process 
  • Provide ongoing input and support to the MRB team members, support continuous process improvement initiatives , share their technical knowledge and promote best practices.
  • Responsible for prioritisation of their proposed mitigation plans and/or acceptance of Quality Risks identified as part of the Quality Risk Management Process under the remit of their role and responsibility.
  • Support the building and fostering relationships with internal and external stakeholder.
  • Ensure timely completion of Supplier change control tracker to help the team track the overall MRB process against commited timelines .
Qualifications

Skills & Experience:

  • Works independently with all levels of the organization 
  • Knowledge of supply chain systems 
  • Demonstrated knowledge in one or more pharmaceutical and/or chemical manufacturing operation (e.g. manufacturing, quality, engineering, etc.). 
  • At least three years’ experience in the Pharmaceutical industry or a similar operating environment with experience in a supply chain or Technical role in a manufacturing environment.
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements.
  • Demonstrated leadership skills with a continuous improvement focus.
  • Knowledge of Project Management skills for leading projects.
  • Process and technology background.
  • Demonstrated ability to realize improvement initiatives, through leadership of teams.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
  • Demonstrated level of problem solving and facilitation skills.
  • Advanced PC skills such as Excel, Word, and PowerPoint.
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.

Qualifications:

  • Degree in Science or Engineering discipline (preferably MSc).
  • Desirable evidence of Continuous Professional Development.
  • Desirable for Six Sigma Green Belt.
  • Desirable project management qualification such as PMP etc.


Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.

MSD is not accepting unsolicited assistance from search firms / recruitment agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD. No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.


Job: Engineering Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Medical, Engineer, Law, Risk Management, Lean Six Sigma, Healthcare, Engineering, Legal, Finance, Management

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