Job Reference: J5632764
Updated On: 14/01/2020
Status: Open to Applications
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Role OverviewThis is an opportunity for a Validation Consultant to join a leading Pharmaceutical company.
As the Validation Consultant you will be responsible for the development and implementation of the strategies for the qualification or the manufacturing unit and equipment, and leading the Validation activities.
Key Duties and ResponsibilitiesYour duties as the Validation Consultant will be varied however the key duties and responsibilities are as follows:
1. As the Validation consultant you will be responsible for technical validation activities as part of the facility design, build and qualification project by hands-on work.
2. Your role as the Validation Consultant will be to support the Validation of Production Manchinery, Packaging Lines and Filling Lines in a Sterile / Aseptic / Clean Room environment to GMP standards as defined by the FDA and MHRA.
3. As the Validation Consultant, you will complete IQ/OQ as appropriate of plant and equipment, reviewing documentation and advising team members to deliver best practice.
4. As a key member of the team, you will contribute to the overall validation strategy for the site as well as act as a technical point of contact for internal and external stakeholders.
5. Your role as the Validation consultant will be to participate in and respond to inspections by Regulatory Authorities including MHRA and FDA, representing the validation function.
Role RequirementsTo be successful in your application to this exciting opportunity as the Validation Consultant (Manager) we are looking to identify the following on your profile and past history:
1. Relevant degree or qualification in a Scientific or Engineering related discipline.
2. At least 5 years’ of leading and conducting validation activities in a GMP licensed facility that includes aseptic and/or sterile manufacturing.
3. A working knowledge and practical experience with participating in the introduction of new processes and equipment into a GMP manufacturing facility.
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