CQV Quality Assurance Specialist - BioPharma - Dublin


Location: Ireland

EUR 45 - 55 Per Hour

Job Type: Contract

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-2205-29479

Consultant: Karen McHugh






Are you a CQV Quality Assurance Specialist with 5+ years of experience with Validation in project related activities i.e. Experience of the Validation lifecycle particularly the qualification of process equipment, utilities and HVAC associated within a Drug Substance facility?

If you have the relevant experience, send your CV to karen@jobcontax.com or call Karen on +353 17978720 for a confidential chat.


CQV Quality Assurance Specialist - BioPharma - Dublin


Job Description

Our Client is one of Ireland's leading EPCm consultancies and a global player in the Semiconductor, Pharma and Biotech sectors.

Provide Quality oversight on the design and qualification activities as part of the design, construction, qualification and start-up of a facility at the Dunboyne site.

Supporting the qualification and validation activities and agreeing best practices in line with applicable GMP Regulations.

Quality SME for the execution and reporting phases of the qualification and validation activities associated with the facility.

Review and Approve all documentation where required specific to Qualification / Validation activities.

Ensure any investigations / deviations associated with the validation activities are thoroughly investigated and closed in a timely manner

Oversee the Project Change Management Process and approve Project Change Requests where required.


Requirements

Significant experience in a QA/Validation related position within the pharmaceutical or life-sciences industry.

Experience with Validation in project related activities i.e. Experience of the Validation lifecycle particularly the qualification of process equipment, utilities and HVAC associated within a Drug Substance facility.

Strong experience in Validation to ensure compliance to Annex 15, EU regulations, applicable US FDA Guidelines and ASTM E2500

Strong experience of Computer System Validation regulations in line with 21 CFR Part 11, Annex 11 and Annex 15.

Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products.

Track record of utilizing Risk Based Approaches to Qualification / Validation activities.

Strong track record of identifying, escalating and correcting compliance issues and implementing process improvements.


Package

Minimum 12-month contract

Pay rate €45 - €55 per hour


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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