CQV Specialist - QRA - North Dublin - Dublin


Location: Ireland

EUR 50 - 60 Per Hour

Job Type: Contract

Industry: Biotech-Pharma-Medical-Device-Jobs

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 karen@jobcontax.com or call Karen on +353 17978720 for a confidential chat.


CQV Specialist - QRA - North Dublin - Dublin


Job Description

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


Requirements

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


Package

Minimum 12-month contract

Pay rate €50 - €60/h


Contact

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 karen@jobcontax.com or phone +353-1-7978720 for a confidential chat.


JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of CQV Specialists in Dublin and Ireland.


Due to the large volume of applications, JobContax may not be able to respond to every individual.


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