Title of Post: / Validation Specialist
Grade: / B
Department/Directorate: / Validation Compliance Unit
Accountable to: / Process Validation Manager
Liaises with: / Production, R&D Medical, Engineering and Technical Departments
Main Job Purpose
To take responsibility for key aspects of the day-to-day operation of the Validation Compliance Unit as outlined in the duties below, and deputise for the Senior Validation Engineeras required. To deliver and support on the job training, manage and perform, investigative work. Perform qualifications as directed by the Validation Manager. To contribute to the services provided by the Validation Compliance Unit, through competently following the quality systems and requirements laid out in the Site Validation Master Plan.
Organisational Structure
Key Duties and Responsibilities
- To ensure that the routine requalification of defined critical items of manufacturing equipment and services are planned and carried out to meet production schedule requirements.
- To determine and write the procedures to be used on validation exercises and projects according to cGMP and Regulatory (MHRA and FDA) requirements and to manage those exercises and projects.
- Generate and execute detailed and complex validation documentation including validation plans, protocols and reports.
- To liaise with other members of VCU staff so that the necessary fully trained support is provided in other areas of expertise for successful completion of the projects / exercises for which the post holder is responsible.
- To take responsibility for the co-ordination and planning of a defined area of work, to achieve successful completion of routine objectives.
- To ensure that up to date authorised documentation is generated in a timely manner for all validation exercises and projects for which the post holder is responsible.
- To supervise and train others in areas where the post holder has specialist knowledge.
- To investigate, develop and implement improvements to validation procedures.
- To advise on validation requirements necessary in area of expertise to maintain compliance with current GMP and regulatory requirements, within the post holder’s area of technical specialty.
- To liaise and co-operate with other departments to carry out Validation activities and changes as necessary to meet cGMP and regulatory requirements.
- To use a variety of sophisticated computer software packages intended for data analysis and collation and other related applications (e.g. Validator 2000 and Comark Dataloggers).
- To ensure compliance with Health and Safety and Environmental requirements.
- To ensure that all VCU validation equipment is maintained and calibrated in a timely manner, to agreed standards.
- To ensure that they comply with relevant BPL Policies and Procedures.
- Other tasks as necessary to maintain the effective functioning of the Validation Compliance Unit as required by the Validation Manager.
Acceptance and Review
Accepted
Manager’s Signature...... Print Name………………...... Date......Jobholder Signature...... Print Name………………...... Date......
h:\d05\data\pers\recruitment\job descriptions (jd)\validation\validation specialist jd feb 16.doc
1