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Our Pharmaceutical Client is looking for a Manufacturing Lead to join their busy team in West Wales. The role would be to ensure that the Production facility at the Wales site is in a fully cGMP compliant and inspection ready state at all times. 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 to 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.
- To ensure the Commercial manufacturing facility is in a state of regulatory compliance at all times. 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 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 departments quality metrics and SLAs.
- To foster and encourage Continuous Improvement within the Production department. Lead process improvement initiatives and activities to influence change.
- Ensure compliance with all local laws regulating commercial activities and 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 the Client’s values.
- To perform other work as directed by the Line Manager.
- Accountable to – Site Director, Wales.
- Accountable for – Senior Production Technicians
- Internal – Liaises with all other departments both on site and across the Group at all levels as required.
- External – Maintains external contacts as necessary, e.g., professional groups, suppliers, contractors and service providers.
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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