Validation Specialist - Sterilisation
Location: Hertfordshire/ Bedfordshire
Our Client - a leading Pharmaceutical company are looking to appoint an experienced Validation Specialist to work at their prestigious site; the successful candidate will be given the chance to work with some of the best technologies and will be offered further career scope in the growing validation/ process improvement team.
Reports to Validation Manager
- Ensuring compliance with all applicable (EHS and GxP) regu latory and internal QMS standards and industry best practice.
- 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.
- You 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.
- Collective responsibility for the ongoing compliance of all assets at the different sites 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.
Essential Skills :
- Must have worked within a in Sterilisation Validation (SIP)
- In depth knowledge of the requirements of EN285 and its practical application when validating porous load sterilisers.
- In depth knowledge of the requirements and expectations associated with depyrogenation validation.
- In depth knowledge of the requirements and expectations associated with Hydrogen Peroxide bio decontamination.
- Fully conversant in the requirement and expectations around cycle/load development and worst case challenging of sterilisation/depyrogenation/bio decontamination processes.
- Practical hands-on experience of executing sterilisation/depyrogenation/bio decontamination validations.
- You understand, can clearly explain and would be able to train others sterilisation/depyrogenation/bio decontamination validation.