QA Specialist
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| Job Type | Permanent |
| Area | Dublin |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 2941 |
| Job Views | 2096 |
- Description
- Team Horizon is seeking a QA Specialist for our client’s diverse team at their manufacturing facility in North Dublin.
In this role you will enhance and maintain the quality oversight and compliance systems of validation activities and be involved in supporting and coordinating day to day activities in the areas of cleaning, facilities and equipment validation and will participates in knowledge transfer activities to become a QA Subject Matter Expert on new and developing processes.
Why you should apply:
Join a company whose goal is to help patients live healthier lives and are proud to be a Great Place to Work.
Be part of a diverse and dynamic team where you will have the opportunity to work with experienced leader in a globally recognised biotech company.
What you will be doing:
Represent the site Quality Assurance Department as SME in compliance,
Manage / Input into SAP / POMs refinement initiatives,
Liaise with Site Operations and BTS functions as necessary to support compliance initiatives,
Co-ordinate compliance activities for all systems for Manufacturing, Laboratory, and IT areas
Track and provide relevant quality metrics to Quality Management as required
Perform quality risk assessment of all GMP documentation systems and support stakeholders in the mitigation of compliance risks and Support the Site Risk management efforts
Heavily involved in the coordination, building and approval of the site PQR requirements
Write, Review or Approve site CAPAs, LIRs and Complaints,
Compile and Deliver quarterly Quality Management review
Conduct Internal and External Audits and support preparation
Roll out Data Integrity Quality Plan for the site.
Management of the Change review board and associated activities around metric reporting for changes across the site
Complete Supplier onboarding and approval, and material release from said suppliers in conjunction with appropriate above site global functions
Generation and progression of documents managed through the document management system and generation of metrics to be reported as part of management review.
Be current with regulatory requirements,
Ensure alignment between the local and global procedural requirements and QRM initiatives,
Write, Review and Approve protocols, reports and SOP’s to effect compliance gap remediation as appropriate
Seek and deliver on process innovation and continuous process improvements,
What you need to apply:
Relevant industry experience (5+ years preferred) including strong knowledge in GMP regulations working in a pharmaceutical, biotechnology or medical device industry,
3+ years of experience in a quality assurance role
Experience in compliance requirements including Eudralex, 21 CFR Parts 210, 211, ICH Q9, Q10 and other applicable regulatory requirements.
SAP or ERP system experience
Excellent communication and interpersonal skills, including technical writing.
Strong analytical and problem-solving skills
Goal focused, Demonstrate passion and energy,
Basic Microsoft Office Suite skills.
