Description
Due to further expansion I have an opportunity for two clean room production leaders with a global pharmaceuticals firm in surrey, the company are seeking candidates who have proven ability leading/supervising a team.This role will server as a high profile member of the production team who provides direct support to the Production lead in the efficient running of the manufacturing area. To be responsible on a day-to-day basis for the direct line management of a shift within the production area and ensure the manufacture of Medical devices, pharmaceuticals, intermediates and other products meet defined standards of quality, cGMP and EHS. Leads continuous improvement activities within the area and ensures that cost effective and compliant systems are put in place. Accountable for the generation and ownership of quality event CAPA's, along with change control generation and completion. Ensures the efficient running of the facility and ensures adherence to the manufacturing schedule.
Principal Responsibilities:
To ensure that the manufacturing facility and the activities that take place within it are always compliant with cGMP and EHS regulations and support the management of teams via the Production Lead.
To ensure applicable production systems and processess conform to all cGMP and Validation requirements. Supports site Change Control and Validation for new Equipment, Automation Systems and Cleaning. Provides resources to support on new product introductions as well as significant changes.
To review the shift manufacturing planning schedule and proactively support and manage the production team to meet it. Where required lead business projects through to completion for the production area. To lead Continuous Improvement (CI) initiatives using Lean/Six Sigma tools and principles. To promote the use of CI tools and principles within production.
To help develop the shift team in the CI concepts and progress improvements by communicating the realisation benefits achieved. To use Statistical Process Analysis and Batch data to improve and further optimise processess.
To ensure all operations follow Standard Operating Procedures (SOP's), Quality Records (QRs) and Batch Manufacturing Records (BMRs) and to participate in the generation, completion and review of such documentation to agreed timelines. Review includes full BMR sign off, when required.
To ensure that the Production Team performs and records cleaning of process equipment and plant in accordance with relevant documentation and procedures. Complete assessment of cleaning activities to ensure the facilities meet requirements.
To conduct, review and generate metrics for batch manufacturing data collection activities and ensure such data that has been collected is accurate and utilised to monitor the performance and consistency of the process.
To generate KPIs of EHS incidents and cGMP events to agreed timelines using the required business systems.
To lead, when required, and/or participate in subsequent root cause investigations and perform corrective and preventative activities that may be assigned, on time.
Education and Experience:
Ideally educated to HND/C or degree standard in a relevant Science subject and / or extensive experience of effectively supporting a team in an operations business with senior technical experience in a similar manufacturing environment.
Excellent understanding of cGMP and EHS legislation. A strong understanding of Lean Manufacturing and application of suitable techniques, six-sigma, desirable.
Computer literate (proven ability to use Word, Excel, Project) Experience of acting as a project leader for either continuous improvement or other activities with clear benefit delivered to the company. Engineering and maintenance or quality assurance experience/skills desirable.
Experience of collating and presenting departmental KPIs.