Job Description

PM Group is seeking a Senior Validation Specialist to join a client in the Hertfordshire region.

Scope of Work:

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Perform qualification and validation of manufacturing equipment, analytical test equipment, facilities, services, computerised systems and processes in line with company procedures

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Write qualification and validation lifecycle documents including impact risk assessments, electronic record, electronic signature and data integrity assessments, GAMP assessments, user requirement specifications, design qualification, installation qualification, operational qualification, performance qualification.

* Support maintenance of the validation master plan, requalification and periodic reviews of validated facilities, utilities, equipment and processes.

* Provide project teams with expert validation guidance and best practices for system implementation.

* Lead and own project plans for more complex validation projects.

* Work effectively with and lead cross functional team members to deliver validation projects to schedule.

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Manage work with third-party vendors and suppliers to deliver equipment and validation services to the required company standards.

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Author internal company reports and regulatory documentation.

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Participate in and support internal and regulatory authority Quality inspections.

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Participate in inspections as a subject matter expert.

* Assist in the development and maintenance of validation-related procedures.

* Undertake any other reasonable tasks that are requested to help ensure that appropriate compliance is achieved and maintained within the company’s validated systems.

Requirements:

* Directly relevant biotechnology, pharmaceutical or medical device industry experience

* Prior experience with biopharmaceutical or related industry processes and validation

* Prior experience in qualification of biopharmaceutical (or related industry) process equipment and processes

* Understanding of and familiarity with regulatory guidance governing cell-based and biopharmaceutical development

* Thorough knowledge of cGMP as applied in biopharmaceutical or related industry

* Thorough knowledge of cGMP pharmaceutical quality systems (change control, deviation and CAPA processes)

* Isolator experience

Onsite

18 month Contract

Inside IR35