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Senior quality assurance specialist

Dundalk
beBeeQuality
Quality assurance specialist
Posted: 10 August
Offer description

Exciting Opportunity for Validation Expert

We are currently recruiting for a leading Biopharmaceutical organization based in Dundalk, Ireland.

This is an excellent position for anyone looking to join a multinational company that excels in their field. Key responsibilities include:

* Executing qualification and validation activities as part of a life cycle approach, following validation plans and complying with cGMP and procedures.
* Authoring, reviewing, executing, and approving testing protocols and reports.
* Participating on project teams, vendor inquiries, and troubleshooting and monitoring process systems.

The ideal candidate will have a minimum of 3-5 years of experience working in a pharmaceutical or similar GMP environment, with expertise in commissioning and qualification/validation of facilities, utilities, equipment, and instruments. Additionally, they should be experienced in maintaining the validated state, requalification/revalidation (CTUs, Cleanrooms, Clean Equipment), and providing technical and engineering solutions for GMP manufacturing operations and equipment in a biologics processing environment.

They will also act as a role model for the Validation function and the wider organization in adherence to corporate core values.

Responsibilities include:

1. Validation activities
2. Testing protocols and reports
3. Project teams, vendor inquiries, and troubleshooting

Requirements:

* 3-5 years of experience in a pharmaceutical or GMP environment
* Commissioning and qualification/validation expertise
* Maintaining validated state, requalification/revalidation, and technical solutions

Benefits:

The successful candidate will have the opportunity to work with a leading Biopharmaceutical organization and contribute to the development of innovative products. They will also have access to ongoing training and professional development opportunities.

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