Brief Description:
The Process Technician Senior 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.
Essential Functions/Responsibilities
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.
* To perform a leading and proactive role within the production areas to ensure procedures are followed correctly and tasks completed in a timely manner.
* 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.
Required Knowledge, Skills, and Abilities
* 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.
* 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, 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.
Required/Preferred Education and Licenses
* Minimum of 3 years 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.
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