Ultimately this person will be responsible for leading and executing the complete delivery of capital projects and the associated activities for manufacturing at the company site, ensuring all goods manufactured and services provided, meet the quality requirements of their customers and regulatory authorities. This role will have particular emphasis on the Commissioning, Qualification and Validation activities.
- To lead and execute validation activities and validation assignments supporting all technical, manufacturing and packaging activities involving the qualification of new and existing facilities, utilities, equipment and computerised 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.
- Continuously improve methods of validation in line with Regulatory requirements that ensure BTG is at the forefront of current thinking and are applying best available technique.
- Support the Technical Compliance, Commercial Development, Engineering and Manufacturing teams with items related to Validation.
- Represent the company at Regulatory Inspections
- Ensure that all critical changes are impact assessed and that appropriate controls/actions are in place to secure ongoing manufacture.
- 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 company values.
- Carry out other reasonable tasks as required by the Line Manager.
- Degree in an appropriate scientific discipline and/or relative industrial experience
- Experience in pharmaceutical and/or medical device process and equipment commissioning/qualification for manufacturing/packaging equipment, computer systems, facilities and utilities
- Experience in front line involvement with Regulatory Inspections.
- Excellent understanding and hands-on working knowledge of cGMP, quality and regulatory requirements.
- 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.
Relevant Skills & Behaviours
- 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
- Ability to identify, organise and communicate complex technical problems with strong attention to detail and organisational 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