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Date: Nov 15, 2017

Location: Cork, IE

Company: MSD

Requisition ID: MAN004571

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.

MSD Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Specialist will provide Quality oversight, support and expertise to GMP related activities and Quality Systems in the Integrated Process Team (IPT) and in meeting the Merck Manufacturing Division (MMD) Priorities of: Compliance, Supply, Strategy and Profit Plan.

The team working style is one of collaboration, coaching and facilitation to ensure the success of the site. The Quality Specialist will provide support to Operational Quality in the IPT and across site (as required).

Primary activities/responsibilities:

• Provides to the IPT knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. Deviation/NOE/LIR coaching; GCM coaching, environmental monitoring program, etc.
• Uses knowledge to improve Quality Systems and/or Operational Quality;, provide continuous improvement and execute tasks.
• Ensure supply of high quality product through the implementation and oversight of the Quality Management System for the site.
• Understands and applies regulatory / compliance requirements to their role.
• Responds to standard requests from customer needs
• Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
• Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together
• Ensure the highest Quality, Compliance and Safety standards
• The Quality Specialist will participate and comply with the MMD Quality Management System (QMS) requirements, including ownership.

Qualifications

• 1 - 3 years’ experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes experience in a Quality function.
• Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
• Operational experience of at least 4 QMSs
• Degree in Science, Engineering or similar
• Lean Six Sigma Yellow Belt or suitable alternative
• Demonstrated use of Leadership Behaviours
• Quality Assurance knowledge, from both operational and educational experience
• Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site
• Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
• Good communication, interpersonal skills and ability to work across teams.
• Demonstrated ability to drive the completion of tasks
• Proven decision making capability with accountability and responsibility
• Demonstrated ability to solve problems


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. 






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


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