Validation Specialist Role
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This position involves joining a pharmaceutical client in their state-of-the-art facility on the west coast of Ireland. You will work alongside a talented team in a picturesque seaside town rich in Irish culture and modern amenities.
The opportunity is for a 6-month contract, allowing you to experience life in this unique location while developing your career.
Key Responsibilities:
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* Data Integrity Compliance:
* You will ensure that all computerized systems are qualified in accordance with data integrity policies and regulatory requirements.
* Site Equipment Validation:
* You will coordinate and participate in the validation of site equipment, facilities, utilities, processes, and software, adhering to company policies, FDA, European cGMP, and GAMP standards.
* Validation Planning:
* You will generate and maintain validation master plans and develop project validation plans.
* Documentation and Review:
* You will generate validation plans, protocols, and final reports to cGMP standard and review and approve all protocols and final reports.
* Change Control Management:
* You will manage the validation change control process.
Required Skills and Qualifications:
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* A bachelor's degree 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 the ability to adapt to new regulatory requirements.
* Innovative thinking, proposing, demonstrating, and implementing new and untested solutions on a regular basis.
Benefits:
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* Experience working in a global pharmaceutical environment.
* The opportunity to work in a state-of-the-art facility.
* Collaboration with a talented team in a picturesque location.
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Others:
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Please note that this is a contract role and the duration is 6 months.