Process Coordinator

Job title: Process Coordinator

Location: Swindon

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Responsibilities:

• Complete all activities to successfully acquire and maintain a Bronze license Badge – Production areas (Grade C/D) access. Maintain the Bronze license through successful requalification every 2 years.

• To lead by example and provide Management and Leadership of the team aligned to the company culture, values and behaviors.
• To be accountable and responsible for all associated activities in the absence of the Section Head.
• Ensure all team members are multi skilled to perform tasks, effectively, safely and in compliance of procedures. Effectively utilize the resource across the business to minimize increases in headcount.
• Ensure each member of the team has a personal development plan and objectives aligned with corporate and site goals.
• Deliver the weekly production schedule by ensuring, skills, materials, components, equipment and documentation are available on time and in full.
• Have a detailed knowledge and understanding of products and processes to enable improvement and Lead and support client and regulatory visits and inspections.
• Be accountable for ensuring all associated batch documentation is completed in real time, undertake frequent daily routine checks and ensure all BMR entries are compliantly completed (including all SAP transactions).
• Agree measures of performance and targets with the Section Head, the targets will be cascaded appropriately.
• Embrace and undertake an active role in Practical Process improvement (PPI) and Operational Excellence and support the implementation of continuous improvement initiatives and ideas.
• Support the introduction of new products, equipment and processes.
• Be accountable for the ordering and usage of consumable items to ensure financial control.
• Be accountable and responsible for ensuring deviations and CAPAs are effectively closed on time.
• Ensure the facility is appropriately kept clean and tidy in line with 5s principles.
• Identify opportunities to Lean the process, eliminating or reducing waste and or non-value adding activities.

GMP:

• Through a presence in the workplace, coach and mentor staff to ensure products are manufactured and documentation completed in accordance with GMP, Standard Operating Procedures and other regulatory agency requirements.
• Timely completion of relevant deviation and complaint investigations to identify true root cause. Along with timely closure of corrective/preventative actions for deviations, complaints and GMP audits that are assigned to them with a focus on improved processes, documentation, documentation completion and training.
• Completion of surveillance audits & support for Self-Inspection audits in areas you are responsible for.
• Maintain a high level of tidiness and cleanliness at all times – personal, personnel, work area and department.
• Maintain a Bronze badge license, hold or work towards a Silver License badge for aseptic filling.

EH&S:

• Understand emergency procedures and comply with safe systems of work.
• Ensure compliance with environment, health and safety rules, signage and instructions at all times.
• Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.

Minimum Requirements/Qualifications:

• Technical writing skills – reports, investigations, SOPs.
• Experience working in a pharmaceutical (desirable), other regulated production operations such as the food industry (essential)
• Leadership experience and supervisory management qualifications, preferably to NVQ level 3 or equivalent.
• Lean manufacturing and/or Lean Six-Sigma training and experience desirable.

Our global team of more than 100,000 colleagues delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.