Clean Room Lead - Pharmaceutical

Dart Recruitment Ltd
£35000 - £40000/annum
17 Jul 2017
16 Aug 2017
Contract Type
Full Time
Our international Pharmaceutical Client is hiring a Clean Room Lead to join their team in Farnham, you will be a high-profile member of the production team who provides direct support to the Production Manager 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 to ensure the manufacturing of bio-pharmaceuticals, intermediates and other products meets 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 Manager.
- To ensure applicable production systems and processes 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 processes.
- 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.
- To proactively lead the department in the setting, monitoring, delivery and analysis of the site and departmental objectives and ensure that the production area achieves all defined metrics consistently.
- Collation and generation of Shift Team`s metrics (i.e. EHS, Right First Time, Quality, Compliance, Schedule Adherence)
- Perform appraisals and other performance management activities (e.g. probationary reviews, disciplinary procedures)
- Perform recruitment for the Production Team as and when required.
- Assist the Production Manager with generating, implementing, monitoring and delivering development plans and training of production personnel in accordance with agreed training modules and timelines.
- Ensure that quality and safety audits are carried out and documented to the agreed schedules and ensure corrective and preventative actions are completed on time.
- Responsible for ensuring sufficient resource is available to cover Production requirements at any time.
- Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with the Client`s values.
- To deputise on behalf of the Production Manager as required
- Carry out other reasonable tasks as required by the Line Manager.
- Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with the Client`s
- Carry out other reasonable tasks as required by the Line Manager.

Principal Relationships

- Accountable to – Production Manager
- Accountable for – Senior Production Technicians, Production Technicians
- Internal – Liaises with all other departments both on site and across the group at all levels as required.
- External – N/A

Education and Experience required

- 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
- 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

Skills and Attributes required

- Must have good listening skills and be able to follow instructions and guidance.
- Needs to be methodical, organised and show attention to detail. Organisational skills should be strong with an ability to plan ahead.
- Ability to challenge existing processes with an eye for detail, to ensure that practices are continuously updated and operating in the most cost efficient and compliant manner.
- To be a leader of Continuous Improvement.
- Must be able to work as part of a team and demonstrate initiative when required with a flexible and willing attitude at all times.
- Confidence and ability to take responsibility for manufacturing operations in Production Manager`s absence and deliver clear instruction to their team