CQV Quality Assurance Specialist - Biotech - Meath


Location: Ireland

Negotiable

Job Type: Contract

Industry: Engineering-Design-Jobs

Job ID: JO-2110-28052

Consultant: Karen McHugh






Are you a Quality Assurance SpecialistĀ  with significant experience in the pharmaceutical or life-sciences industry?

This contract role is based in Meath.

please send your CV for review to karen@jobcontax.com or callĀ +353 1 7978720 to discuss in confidence.


CQV Quality Assurance Specialist - Biotech - Meath


Job Description

Our client is an award winning international engineering consultancy, currently undergoing rapid growth.

As part of this role you will:

Provide Quality oversight on the design and qualification activities as part of the design, construction, qualification and start-up of the new BioNX 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 BioNX 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.

Strong 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

Negotiable, based on experience.


Contact

Karen McHugh is the consultant managing this position.

If you are a CQV Quality Assurance Specialist interested in roles based in Meath, 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 Quality Assurance Specialists in Meath and Ireland.

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


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