Expert Validation Professional

2 days ago

Sligo, Sligo, Ireland beBeeQuality Full time €70,000 - €85,000
Validation Expert

We are seeking a skilled professional to join our organization in Sligo, Ireland. Located on the picturesque west coast of Ireland, this is an opportunity to work with a global pharmaceutical client in their state-of-the-art facility.

The ideal candidate will have a strong background in validation and quality assurance, with experience in regulatory requirements such as FDA, European cGMP, and GAMP standards.

Job Description

Ensure all computerized systems are qualified in compliance with data integrity policies and regulatory requirements.

Coordinate direction and active participation in the validation of site equipment, facilities, utilities, processes, and software in compliance with company policies, FDA, European cGMP, and GAMP standards.

Generate/maintain validation master plans.

Generate/maintain project validation plans.

Generate validation plans, protocols, and final reports to cGMP standard.

Review/approve all protocols and final reports.

Manage validation change control process.

Adhere to and support all EHS & E standards, procedures, and policies.


Requirements
  • 3rd-level qualification in a relevant engineering or scientific discipline.
  • A minimum of 5-10 years' experience in a cGMP regulated environment.
  • A good understanding of regulatory requirements.
  • A high level of attention to detail and mental concentration to ensure accuracy and total compliance with procedures at all times.
  • Proven problem-solving skills and ability to adapt to new regulatory requirements.
  • Innovative thinking, proposing, demonstrating, and implementing new and untested solutions regularly.

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