- Farnham, Surrey
- drh 21/4-1
- Dave 01267 610902
To lead and execute the complete delivery of all validation projects and activities for manufacturing at the Farnham site, ensuring all goods manufactured and services provided by the Company meet the quality requirements of the Company, customers and regulatory authorities.
- To lead and execute Validation activities and Validation assignments supporting all manufacturing and packaging activities at the Farnham site involving the qualification of new and existing facilities, utilities, equipment (including sterilization) and computerized systems.
- Generation of related project documentation including but not limited to validation plans, protocols, reports
- Execution of validation testing for manufacturing and packaging equipment, utility systems equipment and any other study identified in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control.
- Implement revised methods of validation in line with Regulatory requirements that ensure the Group is at the forefront of current thinking and are applying best available technique.
- Provide expertise in sterilisation validation and support external contractors providing sterilisation services.
- Support the Engineering group with engineering activities related to Validation.
- Work directly with members of the CMC team to support technical transfers and process validation activities that are performed with existing and new CMO’s.
- Represent the Group at all Regulatory Inspections, acting as the principle point of contact for validation responses.
- Ensure that all critical changes are impact assessed and that appropriate controls/actions are in place to secure ongoing manufacture.
- Lead validation activities across major projects and will continuously be looking to support continuous validation improvement activities
- Training of staff in Validation procedures and principles
- Support other departmental activities as requested by department management or designate.
- Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with values.
- Carry out other reasonable tasks as required by the Line Manager.
The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.
Education and Experience
- Degree in an appropriate scientific discipline.
- Minimum of 5 years’ experience in the validation and qualification of manufacturing/packaging equipment qualification, computer systems validation, utility systems qualification or process validation.
- Extensive experience in pharmaceutical validation and manufacturing with strong experience of front line involvement with Regulatory Inspections.
- Excellent understanding and hands-on working knowledge of cGMP, quality and regulatory requirements for clinical and commercial material.
- Strong technical background, gained from a highly regulated environment: pharmaceutical, biotechnology or related industry, including exposure to the regulatory requirements affecting validation
- Demonstrated knowledge of cGMPs, MHRA, FDA regulations and current industry practices.
Skills and Attributes
- Technical knowledge, high standards of attention to detail and the desire to see tasks through to completion
- Must be “hands-On” with a wide breadth of validation knowledge to allow adaptability to the different types of validation including Cleaning validation, Sterilisation Validation, Temperature Mapping, Process Validation, equipment validation
- Ability to identify, organize and communicate complex technical problems with strong attention to detail and organizational skills.
- Excellent interpersonal skills being able to communicate effectively with a wide range of individuals and groups due to the changeable, team-oriented, project nature of the work
- Proven ability and desire to continuously improve, by seeking new approaches, generating ideas and demonstrating a determination to secure business advantage from such initiatives.
- Must be a completion driven individual, with the attitude to drive projects to completion in considerable detail
To apply for this job please fill in the form below. You can also upload your CV to support your application.