International Pharmaceutical Manufacturer seeks a Validation Manager to be responsible for the implementation of the required processes relating to commissioning, qualification and validation within the remit of your role (primarily aseptic fill finish processes). On a daily basis you will be ensuring compliance with all applicable (EHS and GxP) regulatory and internal standards and industry best practices. You will be organising and deploying resources effectively to deliver validation services to meet and exceed customer expectation. You will need to be committed to, and passionate about providing a reliable and compliant service to meet and exceed the customer's needs.
Essential Skills :
- Must have significant experience in a leadership or management role within a Pharma, Biopharma or Blood product related setting. Experience with in a Validation role would be an advantage.
- Have the experience of managing teams and happy to work solely as a manager with little cross over into hands on technical work on a daily basis.
- Ensure personnel (internal and external) operating under your remit comply with all applicable Environment, Health & Safety requirements.
- Responsibility for the 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 resources are effectively deployed to meet dynamic and competing business priorities.
- Delivery of implementation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.
- Ensure that risks to product quality, patient safety and/or data integrity throughout the validation lifecycle are understood, transparent and managed through the application of a quality risk management approach.
- Identify skills and competency development needs within the team. Support individual and team development through the Elstree training processes.
- Actively participate in the identification, recruitment and on-boarding of resource (staff and contract) into the organisation.
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