Process Technician Lead Coordinator; FTC

Brief

Description:

The Process Technician Lead Coordinator is responsible for all manufacturing and packaging processes with Botanical Drug Product (BDP) using a series of well-defined and documented manufacturing procedures whilst being in compliance with Health and Safety (H&S) and current Good Manufacturing Practices (cGMP) requirements.

Where appropriate, this role will also include direct people management responsibilities including individual/team performance management.

Quality is a primary focus to ensure all aspects of cGMP are met and product quality is not compromised. The workload is varied with the core areas of responsibility listed below:

• Employees have legal duties under the Health and Safety at Work Act 1974, requiring them to take reasonable care for their own and others' safety, cooperate with employer safety measures (like training and policies), use equipment correctly, and report hazards or defects
• The job holder is responsible for maintaining cGxP and EH&S knowledge applicable to the job.
• Ensure delivery against schedule, for all BDP production batches.
• Ensure all BDP batch documentation have been processed in accordance with cGMP and current procedures.
• Perform routine micro testing in the Commercial Manufacturing Suite (CMS).
• Provides day-to-day leadership in the production areas, assisting the shift Supervisor with support and giving direction to the team, this includes dealing with routine staffing matters occurring within their team, referring issues up the line as required.
• Authoring and reviewing of batch documentation and Standard Operating Procedures (SOP).
• The production department is subject to regular visits by senior management, external bodies and regulatory authorities. The Process Technician Lead Coordinator may be called upon to conduct tours of the BDP Production Facility.
• Completing/reviewing deviations and change controls that may occur during the running of BDP production departments.
• Compiling the Home Office spreadsheet and liaising with other departments to ensure that the figures are correct.
• Liaising with other departments on BDP production scheduling, including supply chain, warehouse, engineering, QC and QA.
• Act as key Point Of Contact (POC) for all key stakeholders (groups), in the absence of the BDP shift supervisor.
• Training of other technicians on new processes/changes to manufacturing techniques.
• Identifying areas for improvement and implementing these improvements where applicable across all BDP production processes/working practices.
• Completing additional tasks assigned by production management that are outside the core duties described above.
• In the absence of the Shift Supervisor, the Process Technician Lead Coordinator will assume all day-to-day responsibilities, including schedule adherence, batch documentation reviews, any EH&S incidents and personnel issues.

• Carries out their work in a way that will not adversely affect their own, or others, health, safety and security or the environment and reports any shortcomings in company arrangements.
• May be required to manage shift supervisors direct reports and ensure individual/team meet expected performance standards. Looks to develop individual/team performance wherever possible and identify and potential individual/team performance issues and work with line management in order to resolve.
• Responsible for all manufacturing and packaging processes with BDP in accordance with cGMP standards, both as an initiator and checker.
• Recording of manufacturing/process conditions in batch documentation and equipment/area logbooks.
• Complete area/equipment cleaning procedures to high standards as illustrated in cGMP practices.
• The job holder may be called upon to provide cover for other internal departments, when the BDP production schedule allows.
• Ensures that all activities undertaken comply with cGMP and EH&S standards as detailed in relevant SOP’s and working practices.
• Authors and updates batch documentation, standard operating procedures and associated forms.
• Responsible for the completion of quality related documentation, such as deviations,…