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Stability & LIMS Quality Specialist Job

Date: Nov 18, 2017

Location: Cork, IE

Company: MSD

Requisition ID: QUA006452

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 stability/LIMS quality specialist will provide Quality support and expertise to the laboratories and ensure supply of quality pharmaceutical products in meeting the MSD Manufacturing Division (MMD) priorities of : Compliance, Supply, Strategy and Profit plan.

The team working style is one of collaboration, coaching and facilitating to provide Quality oversight and expertise to the laboratory team to support a High Performing Organisation.

Primary activities/responsibilities:



  • Deliver a robust Quality Management System to support a flexible, collaborate, multi-skilled teamwork environment.

  • Provide independent quality support, guidance and expertise to ensure the success of each area.

  • Complete stability program activities by participation in such activities as protocol preparation, sample preparation and data management etc.

  • Update Nucleus for all changes and addition of new products.

  • Ensure that Nucleus is maintained and streamlined were possible.

  • Coordinator and communicate the prioritisation of updates and changes in Nucleus to all impacted users.

  • Complete training as required with Nucleus users.

  • Support the review & approval of key quality deliverables including Nucleus LIMS, Change control, trackwise, NOEs, DNs, CAPAs. Etc.

  • Review & approval of GMP procedures (& associated documents) for the lab

  • Participation in inspection of site by CQAC/Regulatory Bodies /third parties.

  • Champion the highest quality and compliance standards for the laboratories.

  • Makes decisions within guidelines and policies which impact QC projects.

  • Champion the highest Quality and Compliance standards for QC labs.

Leadership Behaviours:


Focus on Customers, Including Patients



  • Focus the entire organization on delivering value for customers, including patients, by understanding and meeting their needs.

Collaborate



  • Actively listen and seek to understand differing perspectives; work together to achieve the common goals of the new MSD.

Act with Candor and Courage



  • Speak openly, honestly and with conviction; have the courage to take appropriate risks and make difficult decisions.

Make Rapid, Disciplined Decisions



  • Make timely decisions at the right level with the right data

Drive Results



  • Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.

Demonstrate Ethics & Integrity



  • Adhere to the highest standards of trustworthy and ethical behaviour in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation.

Build Talent



  • Build diverse talent with the capabilities necessary to succeed in our markets; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary.
Qualifications

Required:



  • Degree in IT and/or Science, Quality.

  • Knowledge on software

  • Good analytical and technical skills.

  • Demonstrated change management skills (CEM) with continuous improvement.

  • At least 3-5 years’ experience in the Pharmaceutical industry or a similar operating environment, with a strong emphasis on QC systems.

  • Demonstrated use of Leadership Behaviours

  • Knowledge and experience in interpreting current applicable regulatory requirements and providing independent Instrumentation and validation to the site.

  • Demonstrated ability to work independently and fully realize improvement initiatives with minimal guidance.

  • Demonstrated ability to co-ordinate the work of others.

  • Demonstrated ability to drive the completion of tasks.

  • 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

Desired:



  • Evidence of Continuous Professional Development.

  • Evidence of continuous Professional development

  • Preference for lean Six Sigma Yellow Belt

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: Quality Operations
Other Locations:
Employee Status: Regular
Travel:
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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