Brief Description
* To support BDP manufacturing and packaging lines to meet all scheduling requirements. This will include liaising with Supply Chain and the warehouse to ensure all batch commodities are delivered and available to production lines when required.
* To ensure all finished packs and finished bulk (where required) are delivered to the warehouse in a timely manner.
* To support all start and end of batch activities on the BDP production lines.
* To follow current Good Manufacturing Practices (cGMP) and Health and Safety policies at all times and report any deviations and excursions to the relevant personnel/departments.
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:
* To ensure all deliveries of commodities are delivered from the warehouse and checked in ready for production.
* To help production adhere to scheduling needs by completing all tasks needed to start a production order and to work on production lines when needed.
* Ensure that all manufacturing and related activities are performed in accordance with relevant internal/external quality and safety standards. Ensure the BDP area is ‘audit ready’ and compliant at all times.
* Assist in the review of key area documents, including Standard operating procedures (SOPs), batch documentation, Deviations, Risk assessments.
* Where quality/safety issues arise, participate in investigations into root causes and report to line management in a timely and efficient manner.
* Look to ensure continuous improvement of all BDP activities, share best practice across the production department and wider organisation where possible.
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.
* 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.
* 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 task should it overrun.
* 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 take responsibility for consumables 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.
Working Experience
* Experience in a regulated production environment, ideally within the pharmaceutical or related industry.
* Understanding of cGMP is desirable.
* Good working knowledge of standard Microsoft Packages i.e., Word and Excel.
* Good interpersonal and team working skills.
* High level of numeracy.
* Good communication skills including written and oral.
* Excellent attention to detail.
Attributes and Behaviours
* Focus on delivery.
* Leads by example.
* Develops and maintains positive working relationships with others within team and with key stakeholder groups.
* Shares ideas and information.
* Assists colleagues as and when required.
* Demonstrates a ‘can do’ approach.
* Must work as ‘Part of the Team’.
Required/Preferred Education and Licenses
* Forklift Truck licence preferable but not essential.
* Qualifications gained in the Pharmaceutical industry i.e., NVQ’s or similar qualifications.
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