Quality Assurance Specialist Shift jobs at Msd in Ireland, Dublin

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

Adaptability, Adaptability, Change Control Management, Data Integrity, Detail-Oriented, GMP Compliance, Good Manufacturing Practices (GMP), Key Performance Indicators (KPI), Laboratory Information Management System (LIMS), Laboratory Operations, Lean Management, Logistics Management, Management Process, Mitigation, Nondestructive Testing (NDT), Process Improvements, Quality Control Management, Quality Improvement Programs, Quality Management, Regulatory Compliance, Regulatory Requirements, Sample Management, SAP Enterprise Resource Planning (ERP), Schedule Management, Standard Operating Procedure (SOP) {+ 5 more}

*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.

Job Description

We are currently seeking a Quality Specialist to join our biotech facility. As a Quality Specialist you will provide direct quality support to a production area as part of a Quality IPT (Integrated Product Team). The Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation Practices, and represents quality. You will work as part of a shift roster (days role) 4 days on/4 days on

What you will do:

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
• Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures
• Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aids
• Actively participates in the Tier process and use this forum to make issues visible and to partner with the functional area on resolution
• QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
• Serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation when required.
• Participate as the quality member on cross functional projects
• Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program
• Provides support to internal audits and regulatory inspections
• Coach and guide colleagues to ensure documentation is completed right first time, and to ensure compliance with cGMPs and regulatory requirements
• Collaborate with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans
• Drive continuous improvement and utilise problem solving tools and MPS (Our Company Production Systems) Participate in continuous improvement initiatives to enhance operational efficiency and resolve issues

In order to excel in this role, you will more than likely have:

• Bachelor’s degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline.
• Minimum 5 years of relevant experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations.
• Understanding of QA operations is an advantage
• Evidence of leadership skills coupled with excellent and written communication skills
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,please apply today.

Current Contingent Workers apply

Not Applicable

Adaptability, Adaptability, Aseptic Manufacturing, Biopharmaceutical Industry, Capital Projects, cGMP Compliance, Change Management, Data Analysis, Data Integrity, Decision Making, Documentation Review, FDA Regulations, GMP Compliance, Interpersonal Relationships, Laboratory Operations, Laboratory Quality Control, Management Process, New Product Development, New Product Introduction Process, Operational Efficiency, Pharmaceutical Process Engineering, Quality Assurance (QA), Quality Inspections, Quality Management, Quality Operations {+ 4 more}

*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.