Process Technician Senior Coordinator; FTC

Brief Description

The Process Technician 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:

• 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.
• 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.
• Perform routine micro testing in the Commercial Manufacturing Suite (CMS).
• Liaising with other departments on BDP production scheduling, including supply chain, warehouse, engineering, QC and QA.
• 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.

• Performs 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.
• 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.
• Authored and updates batch documentation, standard operating procedures and associated forms.
• Responsible for the completion of quality related documentation, such as deviations, CAPA’s, protocols and change controls.
• The nature of the work requires the job holder to be flexible, with regards to working hours to ensure that they are available to complete a production process should it overrun.
• Trains and coaches new starters (re-train individuals) in BDP manufacturing and packaging processes.
• Looks for areas of improvement across all BDP manufacturing and packaging processes, in order to improve efficiency and reduce costs.
• Informs department management of any atypical events/deviations immediately.
• Executes additional tasks in order to meet department objectives.
• Potential to act as the BDP department EH&S representative and undertake all of the tasks associated with that role.
• Potential to take responsibility for consumable and critical to quality ordering within the department.
• Ensures that activities under their control are carried out in ways to minimise risks to health, safety, security and the environment.

• Minimum of 1 year experience gained in a regulated production environment, ideally within the pharmaceutical/chemical or food industry.
• Ideally hold qualifications gained in the Pharmaceutical industry i.e. NVQ’s or similar
• Proven experience of team supervision or leadership in Pharmaceutical or related industry
• Displays the attributes encompassed in the company values and encourages their development in others.
• Good level of numeracy.
• Good communication skills including written.
• A good working knowledge of standard Microsoft packages, i.e. Excel and Word.
• Excellent attention to detail.
• Develops and maintains positive working relationships with key stakeholder groups, both internal and external.
• Prepared to challenge the norm and look for areas of improvement, share own ideas and information.
• Good team worker assists colleagues as and when required.
• Demonstrates a ‘can do’ attitude.