Overview
Sr Design Assurance Engineer – Cork
About Your New Employer
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
We'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.
With access to the latest tools, information, and training, we'll help you in advancing your skills and career.
Here, you'll be supported in progressing – whatever your ambitions.
About Your New Job
Demonstrates commitment to the Quality Policy
: Support the application of Design Controls in Product Development and Sustaining Changes ensuring that all changes are compliant with associated Pharmaceutical Regulations and Methods.
Manage and resolve product issues
: Related to manufacturing, quality, or field performance.
Support change control and risk management processes
: Generate documentation in alignment with quality system requirements.
Development and lead the execution of stability plan
: Protocols and reports for drug products through the life cycle of the product.
Coordinate and contribute with analytical test laboratories and teams
: For product investigations, OOS, OOT, and significant change events.
Provide Quality support
: In the resolution of complaints investigation, CAPAs, NCMRs, Deviations, Root Cause Analysis, and regulatory requirement changes.
Summarise clear, concise conclusions
: Make appropriate decisions from test data using excellent analytical and problem-solving abilities.
Use knowledge of Statistical Analysis and Lean principles
: Investigate and solve problems and improve quality.
Act as SME in notified body audits and regulatory compliance
: For areas of expertise.
Work with supply chain, incoming materials, and packaging/labelling
: Ensure product is supplied to stringent quality levels.
Interface with R&D, Regulatory Affairs, Operations, Validations, Clinical, Medical Safety, and Pharmacovigilance
: Provide technical input.
Coach and give technical guidance to Design Assurance Engineer team members
: Support the business growth strategy.
What Skills You Need
NFQ Level 8 qualification in a STEM discipline
Familiar with Minitab and data Analysis
Minimum of 5+ years' experience in the Pharmaceutical Industry
Good technical capabilities, communication skills, teamwork abilities, and initiative
Proven ability to work well both as part of a team but also be able to work on own with minimum supervision
Experience leading/supporting multiple complex projects and assignments
What's on Offer
Advancing possibilities for a brighter tomorrow
Opportunity to work in a diverse and high-performing team
Access to the latest tools, information, and training to advance your skills and career
What's Next
Apply now by clicking the "Apply Now" button or call me on + or email .
Or if the job isn't quite right but you are looking for something similar, please get in touch.
We also have multiple Temp, FTC, and Contract jobs available.
Skills
EMA regulations
Data Analysis
Pharmaceuticals
Quality Assurance
Quality Engineer
Benefits
Paid Holidays
Parking
Pension
Educational assistance
Bonus
Life Assurance
Travel Tax Incentives
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