Job Type: Contract
Job ID: JO-2104-25803
Consultant: Karen McHugh
Are you a CQV Specialist with at least 4 years of experience in commissioning and qualification activities for pharmaceutical facilities?
Do you have extensive experience in Quality Risk Assessments?
If you have the relevant experience, send your CV to firstname.lastname@example.org or call Karen on +353 17978720 for a confidential chat.
CQV Specialist - QRA - North Dublin - Dublin
Our Client is one of Ireland's leading EPCm consultancies and a global player in the Semiconductor, Pharma and Biotech sectors.
Lead the QRM activities required for the New Product Introduction capital projects
Act as QRM facilitator and Risk lead for project Quality Risk Assessments
Schedule the completion of project QRAs and track to completion including tracking to closure associated QRM CAPAs
Ensure linkage from the output of the QRAs to the Commissioning, Qualification and Validation strategies
Support the facilitation of site QRAs which are required for update as a result of NPI
Present QRAs for concurrence at Site QRM Council
Support for Change Management activities
Provide compliance contribution to project teams and leads small project
Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming company and regulatory expectations and compliance changes/challenges
Degree in natural or applied sciences (Biotechnology, Pharmacy, Biology, Engineering)
Minimum 3-5 years pharmaceutical and/or biotech industry experience in Quality/Compliance/Validation related role
Experience in startup biotechnology and drug substance facilities a distinct advantage
Familiarity with Commissioning & Qualification lifecycle deliverables
Sound awareness and understanding of pharmaceutical business, especially with regards to quality, compliance and regulatory requirements
Experience in Quality Risk Assessments, as a participant, risk lead or facilitator
Experience in change controls
Experience in project management.
Demonstrated problem-solving capabilities and technical writing capability
Ability to operate efficiently in a complex matrix organization and global environment
Ability to self-motivate and work independently and as a team
Ability to lead and engage a cross-functional team
English fluency, written and spoken
Minimum 12-month contract
Pay rate €50 - €60/h
Karen McHugh is the consultant managing this position.
If you are a CQV Specialist interested in roles based in Dublin, you can contact Karen by e-mail at email@example.com or phone +353-1-7978720 for a confidential chat.
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