Share this Job
Email similar jobs to meEmail similar jobs to me

Date: Nov 17, 2017

Location: Cork, IE

Company: MSD

Requisition ID: QUA006437

MSD 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.


This position within the QA department will provide Quality oversight, support and knowledge to activities relating to Quality Systems across the site and in meeting the MSD 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 is accountable for the Quality Systems within the site.

This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment.

The Senior Quality Specialist will have proven capability in development of Quality Systems as an active member, across cross functional teams, to deliver process improvement. The Senior Quality 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 Senior Quality Specialist will participate and comply with the MSD Quality Management System (QMS) requirements, including ownership.

Primary activities/responsibilities:


  • Provides to the site knowledge and experience in Quality Systems. 

  • Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.

  • Provides compliance contribution to project teams and leads small projects.

  • Coaches and guides colleagues within the site.

  • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.

  • Responds to non-standard requests from customer needs.

  • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.

  • Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed.

  • Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.

  • Participation in and leading internal inspections

  • Supplier management oversight

  • Ensures supply of high quality product through the implementation and oversight of the Quality Management System for the site.

  • Champion the highest Quality and Compliance standards for the site.

  • Ensure highest safety standards.
Qualifications

Required:


  • Degree or 3rd level qualification (Science, Quality). 

  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation 

  • 3 - 5 years experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function

  • Quality Assurance SME knowledge, from both operational and educational experience, is required 

  • 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 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.

  • Demonstrated coaching skills.

  • Demonstrated ability to solve problems.

Desired:


  • Desirable evidence of Continuous Professional Development.

  • Qualified Auditor.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.



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


Job Segment: Law, Pharmaceutical, Compliance, Supply, Quality Assurance, Legal, Science, Operations, Technology