QA Specialist - QMS Job

Date: Jan 17, 2019

Location: Dublin, IE

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Requisition ID: QUA008100

MSD BIOTECH, DUBLIN

The latest addition to the MSD Ireland family is MSD Biotech, Dublin. The site will play a pivotal role in the manufacture of MSD’s biologics-based medicines, including in the area of immuno-oncology, and will expand MSD’s current internal network of biologics drug substance manufacturing plants when full manufacturing operations begin in 2021.

MSD Biotech Dublin, will be MSD’s first ever Large-Scale Mammalian-Based Drug Substance Facility, with the mission and ambition to manufacture breakthrough medicines from Ireland for patients around the world.

This facility will be a significant supplier of drug substances for one of MSD’s key treatments and will also be critical in the future supply of new biotechnology products to its global network.

& SPECIFIC OBJECTIVES

• The Quality Assurance Specialist - QMS is responsible for active contribution to, maintaining and continuing improvement of the MSD Quality Management System and Site Compliance Plan throughout their knowledge and areas of expertise.
• This position has an important role within the site for the Quality Management System robustness, sustainability and overall cGMP System, Site Quality Council and Operational Compliance.
• Intensive international contact with above Site will be a key part of the job.

POSITION RESPONSIBILITIES

This position will include a combination of the responsibilities listed depending on the phase of the start-up of the site



• Implementing the Change Management system
• Supporting the site Quality Council activities
• Controlling the site Document / SOP management systems
• Managing the review process for Global standards, policies, directives and bulletins
• Corodinating the site Change management system
• Maintaining supplier management including contracts and agreements
• Participate in GMP Training & Knowledge Management
• Implementing and managing the Annual Product Review system
• Site SME/ representative at Global CoE groups pertaining to QMS topics.
• Implementing any changes to the Manufacturing Divison Quality Management System at the site
• Other general specified tasks e.g. Site Master File, Manufacturing License, metrics

• The candidate will provide quality support to the project and site, including training and guidance on the interpretation and implementation of the MSD Quality Manual.


REPORTING STRUCTURE

Reports to the Site QMS Lead

Qualifications

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

General
• A minimum 5 years experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations or Technical Operations

Technical
• Excellent knowledge of relevant Quality and Compliance Guidelines (cGMP, Auditing, Quality Management Systems, Quality Agreements, Regulatory Affairs, Training) and respective regulations

People
• The motivation to be an inspiring member of a high performing team.
• The passion to build the future of MSD Biotech Dublin
• The desire to continuously learn, improve and develop
• A great communicator, decisive decision maker and proven ability to deliver excellence
• Confidence to direct off-site suppliers to the project, willingness to support the team and a lazer light focus to deliver excellence
• Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
• Experience with new product introductions and/or process qualification/technology transfer

Education
• Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or equivalent



Job: Qual Assurance & Ops Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 2
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Microbiology, Biotech, Oncology, Engineer, Law, Science, Healthcare, Engineering, Legal

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