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Senior Quality Assurance Specialist (2yr Contract) Job

Date: Oct 21, 2017

Location: Cork, IE

Company: MSD

Requisition ID: MAN004258



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.


The Senior Quality Assurance Specialist will provide Quality oversight, support and expertise to GMP related activities and Quality Systems in the Biologics Integrated Process Team (IPT) and 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 facilitation to ensure the success of the site. The Senior Quality Assurance Specialist will provide support to Operational Quality in the IPT and across site (as required).

Primary activities/responsibilities:


  • Support start-up activities from a quality aspect to ensure compliance with current MSD Brinny and global MSD procedures.

  • Support all quality and compliance requirements for the Biologics 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.

  • Coordinates the work of others within the team 

  • Acts as a resource to colleagues with less experience in Quality Systems and/or Operational Quality

  • Active member/Lead (as required) within the cross functional IPT team providing quality expertise, support and advice to the IPT team on Quality Assurance and GMP compliance aspects.

  • Works within IPT to ensure supply of high quality product through implementation and oversight of the Quality Management System.

  • 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 to ensure alignment 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 Biologics IPT and MSD Brinny

  • Works with other sites to aid them and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality. 

  • Act as quality sign-off/designee for the Biologics IPT Quality Lead, as required

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.


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 Operations function.

    • Degree in Science, Engineering or similiar

    • Green belt or suitable alternative (desirable).

    • Good communication & interpersonal skills.

    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: 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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