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Validation and quality assurance specialist - medical devices

Sligo
beBeePharmaceutical
Quality assurance specialist
Posted: 8 September
Offer description

Pharmaceutical Engineer Role in West Ireland

Located on the picturesque west coast of Ireland, our pharmaceutical client is seeking a skilled Pharmaceutical Engineer to join their state-of-the-art facility.

The successful candidate will be responsible for coordinating and participating in the validation and quality assurance of site equipment, utilities, processes, and software, ensuring compliance with industry standards.


Responsibilities:

1. Validate site equipment, utilities, processes, and software in compliance with policies, FDA, European cGMP, and GAMP standards.
2. Develop and execute Site Validation Master Plans.
3. Generate project validation plans and schedules.
4. Create validation protocols and final reports according to cGMP standards.


Requirements:

1. Qualification in an engineering or scientific discipline.
2. At least 3 years of experience in validation and quality assurance within the medical device or pharmaceutical industry.
3. Familiarity with cGMP and regulatory requirements related to the medical device industry.

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