A dynamic and innovative validation specialist is required to join our client's state-of-the-art pharmaceutical facility located on the picturesque west coast of Ireland.
Located in the historic province of Connacht, this seaside town offers a unique blend of Irish culture and modernization. The ideal candidate will be responsible for ensuring all computerized systems are qualified in compliance with data integrity policies and regulatory requirements.
Key Responsibilities:
* Ensure all Computerised systems are qualified in compliance with Data Integrity policies and regulatory requirements.
* Co-ordination / 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.
* Generation/maintenance of the Validation Master Plans.
* Generation/maintenance of Project Validation Plans.
* Generation of validation plans, protocols and final reports to cGMP standard.
* Review / approval of all protocols and final reports.
* Management of validation change control process.
* Adheres to and supports 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.
* Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
* Requires proven problem-solving skills and the ability to adapt to new regulatory requirements.
* Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
If you have the necessary skills and qualifications, we encourage you to apply for this exciting opportunity.