Process Validation Specialist

Salisbury, UK
13 Sep 2019
28 Sep 2019
Contract Type
Full Time
Job title: Process Validation Specialist


Locations:Porton Down, Salisbury

Salary: circa £40,000 per annum, negotiable dependant on experience


Job TypePermanent

Our client has approximately 350 staff, performing a range of production, quality and development roles within pharmaceutical production, process and analytical development, quality control and quality assurance. The Company carries out the manufacture of Erwinase® and Anthrax Vaccine as well as contract manufacturing projects.

Job Summary:

This role is to coordinate the timely completion of Process Validation studies in support of PBL manufacturing activities and Regulatory requirements. The role will include the writing, review and execution of process validation plans, protocols and reports and the coordination of support activities to deliver on time a high standard of documentation. The position holder will be expected to attend Project group meetings, liaise with support teams, regulatory bodies and peers to establish data for inclusion into protocols and reports, The position holder should be prepared to execute and witness Process Validation studies in line with the production schedule PBLF-014-03 11 Jan 16 Communication and key working relationship

Duties and Responsibilities:

·To coordinate the execution of the Validation Master Plan with respect to Process Validation activities.

·Assess Change Control documentation to determine change impact with respect to the validation requirements and report appropriately.

·To support operational areas in the implementation of change.

·Supports Process Validation activities.

·Define Process Validation Strategies.

·Author and review Process Validation plans, protocols and reports ensuring compliance to PBL policies and procedures.

·Schedule and support Process Validation executions.

·High level of technical and scientific writing required.

·Understand and apply statistical tools for development of protocols and data analysis for Process Validation (as per current FDA/MHRA Process validation lifecycle guidelines).

·Present Process Validation documents at regulatory audits.

·Perform process investigations with relevant departments as required.

·Perform product and process impact assessments.

·Participate in or lead process and quality risk assessments.

·Present findings at group and at interdepartmental meetings.

·Communicate information on current process data which may impact Process Validation.

·Maintain and review the Product Control Strategy for all products. Understand the functional relationships that link CMA/CPP to CQA.

·To ensure the timely completion of Deviations and the closure of CAPAs

The successful candidate will have the following:

·Have knowledge of Validation Life Cycle documentation deliverables and how to implement a Risk based approach is central to the skills base of this position.

·The role will include the writing, review and execution of Process Validation plans, protocols and reports and the coordination of support activities to deliver on time a high standard of documentation.

·The candidate will have a degree in Science or Engineering or equivalent and recognised academic achievement and have Project Management experience.

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