Process Validation Lead
Posted on Aug 1, 2019 by CV-Library
We are looking for the next addition on the team as a Process Validation Lead for a large biopharma company, the role is offering very competitive benefits and a large holiday package.
- A knowledge of Validation Life Cycle documentation deliverable and how to implement a Risk based approach is central to the skills base of this position.
- The role will include the writing, review, approval (as required) and execution of Process Validation plans, protocols and reports and the coordination of support activities to deliver on time a high standard of documentation.
- Degree in Science or Engineering or equivalent and recognised academic achievement and project management. They will also have people line management experience.
- Attend Project group meetings, liaise with support teams, regulatory bodies and peers to establish data for inclusion into protocols and reports.
- Execute and witness Process Validation studies in line with the production schedule
- define and coordinate the execution of Performance Qualification and Process Performance Qualification activities in support of manufacturing activities and in accordance with Regulatory requirements and to manage the Process Validation team.
The following is a description of the main 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 comapny policies and procedures as required.
- Approve Process Validation plans, protocols and reports ensuring compliance to company policies and procedures as required.
- 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).
- Lead Continued Process Verification activities including the generation of CPV plans and reporting.
- Present Process Validation documents at regulatory audits.
- Performs process investigations with relevant departments as required.
- Performs product and process impact assessments.
- Participates in or leads process and quality risk assessments.
- Presents 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/PP to CQA.
- To ensure the timely completion of Deviations and the closure of CAPAs
- Coordinate Contractor or permanent resources to deliver timely documentation in support of Process Validation activities
Established in 1978, NES Global Talent provides a complete range of contract and permanent talent solutions to the Oil and Gas, Power, Construction and Infrastructure, Life Sciences, Manufacturing and IT sectors worldwide. With more than 40 offices in 28 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. Offering far more than a traditional recruitment service, we fully support our contractors while they are on assignment with everything from securing visas and work permits, to providing market leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients