MSD QC Support Specialist Ireland, Dublin 229628948
Share
Job Description
A fantastic opportunity has arisen for aQC Stability Specialist.In this role, you will be responsible for oversight, management and coordination of the site Stability program and sample management functions. This position carries the remit and accountability to enable the site to meet compliance and regulatory requirements pertaining to Stability and Sample Management.
You will ensure the QC team objectives are effectively achieved, consistent with site requirements ensuring compliance, safety and reliable supply to our customers.
What you will do:
Bring energy, knowledge, innovation and leadership to carry out the following:
Liaise with logistics and warehouse personnel to communicate incoming samples for testing.
Maintain and manage the Stability Program at the site.
Author stability strategies for new and licensed products,
Develop, review and approve stability protocols as per the overall stability strategy.
Monitor Stability program execution – assess cycle time adherence, report KPIs, analyse root causes if/when required, and propose mitigation plans as needed.
Manage and maintain QC metrics and dashboards related to stability and sample management to report out on Key performance metrics
Design and update annual stability protocols as per applicable regulatory requirements
Review and approve stability data to support the assigned expiries and labelled storage statements,
Evaluate and report on stability data annually and as needed, including statistical analysis as appropriate.
Update Global Laboratory Information Management System (GLIMS) for all changes and addition of new stability requirements.
Reviews and approves key stability quality deliverables including GLIMS reports, Change controls, deviations and CAPAs in SAP.
Initiate and manage change controls associated with Stability Program, sample management QC methods, changes to processes pertaining to the QC Labs, updates to Specifications etc.
Initiate and manage deviations associated with Stability program, sample management, testing, processes etc
Assist with Implementation of standardised work, visual management, leaders standard work etc.
Develop program for QC SMEs for preparation for Regulatory Inspections and develop storyboard for key QC topics and processes including Stability and sample management
Be an advocate for continuous improvement.
In order to excel in this role, you will need:
Third Level science qualificationin Science, Engineering or in a relevant discipline, with operational excellence in GMP environment
Minimum of 5 to 7 years’ experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations
Experience in QC (Stability and/or sample management an advantage)
Strong attention to detail with the ability to manage a complex scheduling activity to keep the group on track for success.
Strong ability to organise and prioritise work; ability to create and execute contingency and mitigation plans.
Ability to summarise data and plans into charts, graphs, diagrams, and tables.
Experience with SAP (or similar ERP system) and LIMS is beneficial.
Hands-on application of lean tools and techniques: standardized work, scientific problem solving, value stream mapping, capacity analysis.
So, if you are ready to:
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
These jobs might be a good fit
