Validation Coordinator

Sterigenics UK Limited
11 Mar 2018
19 Mar 2018
Contract Type
Full Time
Reporting to the Quality Assurance (QA) Manager, the Validation Coordinator acting as the facility technical representative is responsible for ensuring the requirements for ISO and QSRs are met and maintained for the facility and its customers. The Validation Coordinator provides management with information and data on all key aspects of each customer’s validation project, which is used by both the plant and the customer to determine the course of routine processing.

Must effectively interface with internal groups (Sales, Radiation Services, etc.) and other Sterigenics facilities in addition to customers and regulatory personnel.

Duties and Responsibility:
• Plans, organizes and coordinates customer (internal or external) validation activities at the facility.
• Writes validation protocols and final reports supplied by the facility
• Prepares and / or monitors preparation of customer product for validation runs including tote fill and dosimeter placement.
• Reviews and approves customer or consultant supplied validation or test protocols for capability within the limitation of the facility’s equipment, Sterigenics operating procedures and compliance with current regulatory standards
• Responsible for the execution of validation protocols and technically driven customer projects, which include but are not limited to the following:
o Scheduling the project runs, ancillary resources and associated activities
o Preparation of necessary process documents (Load Diagrams, Dosimeter Placement Maps…)
o Data collection and analysis
o Assuring proper handling, storage and shipping of testing, engineering, or any other samples to the appropriate internal or external laboratory
• Assures that all validation calibration activities are performed according to Sterigenics procedures and traceable to appropriate national standards.
• Provides support in the performance of IQ/OQ/PQ activities for new or existing facility equipment and software.
• Provides on-going training to relevant personnel on validation topics / projects as maybe required.
• Maintains the quality and integrity of information required for validation records
• Liaison for all plant and customer activities responding to customers’ inquiries whether directly or through Quality Assurance, Customer Service, or Sales to ensure prompt and accurate communication related to technical and validation issues
• Performs other duties as required by the QA Manager to support the overall plant operation and quality system.

Supervision Given:
• Does not supervise the work of others.

Education Required:
• Minimum BA or BS in a science related field or combination of relevant education and experience.

Experience and Skill Required:
• Two (2) to three (3) years’ experience in the pharmaceutical, food or medical device industry or similar regulated environments.
• Direct experience in sterility assurance or product sterilization a plus
• Must have experience in writing and executing validation protocols
• Experience with all or a combination of ISO 9000 / 13485 / 11137, FDA Regulations and European GMPs is a plus.
• Experience in Audit scenarios is a plus.
• Excellent written and verbal communication skills, ability to read and understand technical language is required.
• Strong computer skills.

Special Requirements:
• Must be able to lift and/or move up to 22 kilograms. Specific vision abilities required by this job include close vision.

Salary: Competitive

Please apply online with your CV and cover letter.

Please check your email for confirmation that your application has been received and to follow further instructions if applicable

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