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Senior Quality Specialist Job

Date: Nov 15, 2017

Location: Cork, IE

Company: MSD

Requisition ID: MAN004570

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 Senior 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 Senior 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.
• Support all quality and compliance requirements for the Integrated Process Team (IPT) to enable batch disposition for each batch manufactured.
• Uses knowledge to improve Quality Systems and/or Operational Quality; solve complex problems, provide continuous improvement and execute tasks.
• Acts as a resource to colleagues with less experience in Quality Systems and/or Operational Quality
• Provides compliance contribution to project teams and leads small projects
• 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 together with remaining current on upcoming regulatory and compliance changes
• Interprets customer needs, assesses requirements and identifies solutions to non-standard requests
• Liaises with Corporate Quality, as required, to ensure alignment and execution on actions related to Quality Systems and/or Operational Quality at the site.
• Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow-up actions where applicable
• Champion Permanent Inspection Readiness (PIR) for the IPT and MSD Brinny
• Ensure the highest Quality, Compliance and Safety standards
• Works with other sites to aid them and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality
• The Senior Quality Specialist will participate and comply with the MMD Quality Management System (QMS) requirements, including ownership.

Qualifications

• At least 5 years’ experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes a minimum of 2 years’ experience in a Quality Assurance/Quality Control function.
• Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (i.e. Quality, science etc.)
• Operational experience of at least 4 QMSs and SME in at least 2 QMSs
• Degree in Science, Engineering or similar
• Lean Six Sigma Yellow Belt or suitable alternative
• Quality Assurance SME 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
• Demonstrated use of Leadership Behaviours
• Demonstrated ability to work and succeed within teams as well as leading small project teams
• Demonstrated ability to drive the completion of tasks
• Proven track record of providing independent Quality support to the site.
• Advanced PC skills such as Excel, Word, PowerPoint
• Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
• Proven decision making capability with full accountability and responsibility
• Qualified Auditor (desirable)
• Good communication, interpersonal skills and ability to work across teams.
• 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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