||£400 - £500
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12 Month Initial Contract
Up to £500 per day
You will be part of the Packaging & Delivery Systems group within Global Technology Services and be responsible for marketed combination product Design History File build and enhancements for on-market products. You will ensure the design controls are documented in accordance with internal procedures. Successful candidate MUST have Pharmaceutical experience.
* Responsible for generation, approval and storage of all Pfizer device design control documentation for assigned device projects
* Ensure effective design control activities at external design companies for assigned projects
* Responsible for generation, approval and storage of all Pfizer device risk management documentation for assigned device projects
* Ensure effective risk management activities at external design companies and all manufacturing facilities related to assigned projects
* Responsible for generation, approval and storage of all Pfizer device human factors engineering documentation for assigned device projects
* Responsible for generation, approval and storage of all Pfizer device manufacturing control strategy documentation for assigned device projects
* Provide input and support to human factors usability studies for assigned device projects
* Provide input to purchase specifications for devices and device components
* Ensure effective device design change control, ensuring that quality and regulatory requirements are satisfied
* Work as part of a multidisciplinary team to determine what performance factors of the device are critical to the compliance of the finished product
* Work with Quality Assurance to ensure appropriate quality agreements and purchasing controls with vendors/suppliers
* Work with regulatory to provide all required documentation for regulatory submissions for assigned device projects
* Engineering Degree, or equivalent in relevant subject.
* Background of working in teams in the development, operational or trouble shooting of equipment, devices or manufacturing processes by means of designed experiments and logical problem solving.
* Thorough theoretical knowledge and understanding of degree subject
* Able to anticipate what information is required by their colleagues and to disseminate it actively and efficiently.
To apply please send you CV's in the first instance.