- 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 GW 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.
- 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 GW arrangements.
- Responsible for all manufacturing and packaging processes within 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 maybe 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 SOPs 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, CAPAs, 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 departmental 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 3 years' experience gained in a regulated production environment, ideally within the pharmaceutical/chemical or food industry.
- Displays the attributes encompassed in the GW Values and encourages their development in others.
- Good level of numeracy.
- Good communication skills including written.
- A good working knowledge of standard Microsoft packages, . 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.
- Ideally hold qualifications gained in the Pharmaceutical industry . NVQ's, or similar.
- Proven experience of team supervision or leadership in Pharmaceutical or related industry.
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Process Technician Senior Coordinator - Sittingbourne, United Kingdom - Jazz Pharmaceuticals
Description
Purpose
The Process Technician Senior Coordinator is responsible for all manufacturing and packaging processes within 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.
RESPONSIBILITIES/ACCOUNTABILITIES
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:
ED RESPONSIBILITIES/ACCOUNTABILITIES
ATTRIBUTES/SKILLS/EDUCATION - ESSENTIAL
ATTRIBUTES/SKILLS/EDUCATION – DESIRABLE
