Job Title: Quality Assurance Specialist
Location: County Sligo, Ireland - 6-Month Contract
The key objective of this role is to ensure the validation of Computerised systems in accordance with Data Integrity policies and regulatory requirements.
* Validate all Computerised systems to guarantee compliance with Data Integrity policies and regulatory standards.
* Coordinate and participate in site equipment, facilities, utilities, processes, and software validation activities in line with company policies, FDA, European cGMP, and GAMP guidelines.
* Develop and maintain Validation Master Plans.
* Create and manage Project Validation Plans.
* Prepare validation plans, protocols, and final reports adhering to cGMP standards.
* Review and approve all protocols and final reports.
* Manage the validation change control process.
* Adhere to and support EHS & E standards, procedures, and policies at all times.
Requirements:
* Hold a degree in an engineering or scientific field.
* Possess a minimum of 5-10 years' experience in a cGMP regulated environment.
* Have a solid understanding of regulatory requirements.
* Be able to focus intensely and accurately adhere to procedures at all times.
* Demonstrate proven problem-solving skills and adaptability to new regulatory standards.
* Exhibit innovative thinking by proposing and implementing novel solutions on a regular basis.
About the Role:
This position offers a unique opportunity to join a leading pharmaceutical facility in a picturesque location. As a key member of our team, you will be responsible for ensuring the highest level of data integrity and compliance with regulatory standards.