Process Validation Specialist
Posted on Aug 1, 2019 by CV-Library
Our client is a leading Biopharmaceutical organisation. At present they are seeking a Process Validation Specialist to join their Validation department on a permanent basis at their site in the South West, UK.
The purpose of the Process Validation Specialist role is to coordinate the execution of Performance Qualification and Process Performance Qualification activities as in accordance with regulatory requirements. A knowledge of Validation life cycle documentation deliverables and how to implement a Risk based approach is central to the skills base of this position.
This role is to coordinate the timely completion of Process Validation studies in support of 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
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 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