To ensure that the Production facility at the Wales site is always in a fully cGMP compliant and inspection ready state. Responsible for overall compliance within the clean rooms, ensuring that the fabric is of a high standard, cleaning schedules are adhered to, equipment is maintained in accordance with maintenance schedules and in a validated state.
To lead the Production (Commercial Products) department to ensure that output is manufactured in accordance with cGMP and Regulatory expectations. To maintain Environmental, Health and Safety compliance by ensuring that suitable controls and practices are implemented and maintained according to the latest legislation.
Principle Responsibilities
- To ensure the Commercial manufacturing facility is always in a state of regulatory compliance. This will be achieved through regular facility inspection, close interaction with the engineering and validation departments and a high presence within the facility.
- To ensure that Environmental, Health and Safety Compliance is maintained. Generate a proactive safety culture to reduce the risk of accidents and incidents in the area. Completing, when required, and reviewing departmental risk assessments.
- To manage and support the Senior Production Technicians and Production Technicians in drawing up adequate plans to provide appropriate resources that enable production to be completed in the most efficient manner.
- Responsible for ensuring that the department, premises, and equipment are maintained and operated to the required standards and in a safe manner.
- Ensure that the validation schedule for the facility equipment and systems is maintained.
- Responsible for the delivery of the department’s quality metrics and SLAs.
- To ensure all required end of day and weekly checks within the Production department are completed on time and in full.
Education and Experience
- A degree in an appropriate scientific discipline with proven supervisory and/or manufacturing management experience in a biopharmaceutical or closely related industry.
- Alternatively, a relevant qualification with extensive and strong technical and supervisory/management experience in a biopharmaceutical or closely related industry environment.
- Computer literate.
- Solid understanding of cGMP and Regulatory requirements.
Skills and Attributes
- Proven and well-developed man-management and communication skills essential.
- Proven ability to take responsibility for, motivate and engage a team of individuals utilising good people skills.
- Confidence and ability to train others and deliver clear instruction to individuals.
- Proven problem-solving skills with an open-minded approach and an ability to bring about positive change.
- Ability to challenge existing processes with an eye for detail, to ensure that practices are continuously updated and operating in the most cost-efficient manner.
- Strong presentation skills to enable clear and concise feedback to all levels.
- A flexible and willing attitude is essential.
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Applications are encouraged from all sections of the community.