International Pharmaceutical Manufacturer seeks a Utilities Validation Specialist. As part of the Validation team, you will be taking ownership of all aspects of service delivery which relate to equipment commissioning, qualification and validation within your remit. You will be ensuring compliance with all applicable (EHS and GxP) regulatory and internal Quality standards and industry best practice. You will need to be committed to, and passionate about providing a reliable and compliant service to meet and exceed the customer's needs. This is a customer-facing role, and as such the ability to form relationships across the organisation is essential for success.
Essential Skills :
- In depth knowledge of the requirements and expectation of utilities validation.
- In depth knowledge of the requirements and expectations associated with product contacting clean gasses, WFI and PW validation.
- In depth knowledge of the requirements and expectations associated with HVAC validation and cleanroom classification.
- Practical hands-on experience of executing utility validations.
- Collective responsibility for the ongoing compliance of all assets at the facility within your remit, ensuring that the equipment meets regulatory requirements at all times with a target of zero impact to routine operations.
- Maintain an ongoing dialogue with Validation Management to ensure validation resources are effectively deployed to meet dynamic and competing business priorities.
- Support the implementation validation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.
- Highlight risks to product quality, patient safety and/or data integrity throughout the validation lifecycle so that they are understood, transparent and can be managed through the application of a quality risk management approach.
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