Job Description
A development role has become available for a full-timetrainee cleanroom line technicianto join the existing Production team here atTorbay Pharmaceuticals (TP),This role is initially for 6 MONTHS but has the potential to become permanent .
The job involves working as a member of a small specialist team manufacturing pharmaceutical products within a sterile controlled environment. To be successful in this role you will have good attention to detail and be able to understand and follow written procedures. You will preferably have previous cleanroom experience and will be able to work as part of a team.
Please note that the working pattern is early and late shifts:
Early: 06:30 – 14:45
Late: 11:15 – 19:30
Please note: As part of the production team you will be working within a controlled/graded cleanroom environment whilst wearing specialist cleanroom gowning to minimise contamination
This role is initially for 6 MONTHS but has the potential to become permanent
This role involves chemical preparation, formulation, automatic filling, oversealing of products together with cleaning and sterilising of equipment in compliance with all manufacturing SOP’s, Batch packaging records, in line with H&S requirements and following Pharmaceutical cGMP.
The development role starts as a trainee cleanroom line technician, (Band 2) and then progresses to cleanroom line technician (Band 3) once competency is achieved in the required lines/departments.
Torbay Pharmaceuticals is a flagship business within the National Health Service and manufactures and distributes terminally sterilised injectables for the secondary care market in the UK and worldwide. We believe that by thinking and acting differently we can make a positive difference to people’s lives across the world.
The business employs around 200 people and is achieving year on year growth. Our specialist portfolio includes licensed and unlicensed terminally sterilised injectables, high-quality electrolyte solutions for TPN compounding, and a range of non-sterile oral solutions.
At Torbay Pharmaceuticals you’ll work for a truly unique organisation and alongside the most committed people in the business. We have ambitious plans to grow our business over the next few years and we know that we can’t do that without everyone playing their part. That’s why we believe in the One TP way of working.
Please refer to your suitability to the post in your supporting information from the role requirements or person specification.
Communication and Working Relationships
- Ensuring that the requirements of the Health & Safety at Work Act 1974, and where applicable the Medicines Act 1968 are complied with (e.g. that the Production Operator does not pose a danger to themselves or work colleagues and that all cGMP instructions are complied with)
- To work both as an individual in certain tasks and also as part of a small specialist team within various sections of the Production department
- To read, understand and act on written instructions via batch records and SOP’s, to perform calculations and to record KPI data, calibrate process test instruments, assemble technical equipment and understand product critical quality attributes
- To complete all documentation in a clear, precise, contemporaneous and legible manner in accordance with Data Integrity principles
- To inform the Production Manager, Line Supervisor, Deputy Line Supervisor or any member of the engineering team of anything concerning any defect or issue with a product, equipment, facilities, components, documentation and to check equipment is “fit for purpose” before any production commences
- Communicate effectively with production team members, senior staff, other departments and regulatory auditors
- Work as a member of a small specialist team, valuing the contribution of others and forming co-operative working relationships with all colleagues
- To participate in 5S and sustain the production areas to this standard, and to participate in KPI meetings
- Attend all relevant internal and Production team meetings as requested
- Attend daily production meetings when necessary
- The post holder reports to their team Line Supervisor or Deputy Line Supervisor
- The post holder is in regular contact with all Torbay Pharmaceuticals operational and management personnel
Planning and Organisation
- Demonstrate the ability to multitask when required and respond to a variable workload with unexpected interruptions with changed deadlines. To manage aggressive customer deadlines in relation to on-time/in full product delivery
- Responsible as part of a specialist team for chemical preparation, formulation, automatic/manual filling and over-sealing of products together with cleaning and sterilising of equipment in compliance with all manufacturing SOP’s, Batch Documentation, H&S requirements and cGMP
- To ‘set up’ and operate complex equipment as set out in the appropriate SOP’s
- Responsible for performing daily & monthly cleanroom cleaning activities as set out in the appropriate SOP’s
- Prepares equipment by performing cleanroom cleaning as per cGMP using cleaning-in-place (CIP)and servicing-in-place (SIP) systems
Responsibility and Accountability
- To assist the Production Manager, Line Supervisor & Deputy Line Supervisor in ensuring that the Production department and related activities comply with cGMP, the unit’s ISO accreditation standards and other relevant guidelines, procedures and practices
- To perform the dispensing and preparation of raw materials including specialist and potentially hazardous chemicals as instructed and in accordance with the batch documentation and in compliance with applicable SOP’s and hazard data sheets
- To understand the importance of all activities/perform quality control checks such as IPC’s (in process checks) and process challenges.
- Participate fully in departmental training programmes and ensure compliance of all mandatory training courses
- To undertake any other reasonable duties consistent with the grade as indicated by the team Line Supervisor or Deputy Line Supervisor
- Responsible for the continual effective performance of Torbay Pharmaceuticals cleanroom operations in order to meet the requirements of the production schedule
- Ensure that cGMP requirements are maintained for the area
- Ensure Health and safety regulations are maintained
- To operate cleanroom production equipment and carry out pharmaceutical manufacturing processes under strict cGMP guidelines and regulations required to produce pharmaceutical products
- Carry out daily cleaning activities after completion of the production batch as set out in standard operating procedures in preparation for the next planned production run
- Be able to work within a controlled/graded cleanroom environment whilst wearing specialist cleanroom gowning to minimise contamination
Policy and Service Responsibility
- Responsible for maintaining the cleanroom facility and pharmaceutical processing equipment to the standard of cleanliness and sterility required of Torbay Pharmaceuticals and regulatory guidelines and standards (Pharmaceutical cGMP). To include the sanitisation, maintenance and monitoring of a controlled/graded clean room environment
- To read and understand all applicable SOP’s, to understand the importance of all activities and processes. To understand the importance of the pharmaceutical products being manufactured
- To work both as an individual and as part of a team, to support operational efficiency and continuous improvement programmes and to ensure that at all times all activities comply with “Good Manufacturing Practice”, the units ISO accreditations and other relevant guidelines; H&S guidelines, procedures and practices
Responsibility for Finance, Equipment and Other Resources
- Responsible for basic fault finding and once this process is exhausted responsible for escalating production issues to the Line Supervisor or Production Manager
- Requires the frequent movement of items weighing up to 15kg without the use of mechanical aids in accordance with H&S regulations. Requires frequent movement of loaded pallets and product trolleys
- Occasional handling of hazardous chemicals and materials requiring the
use of personal protective equipment
Responsibility for Supervision, Leadership and Management
- To support, encourage and assist in the training of new starters and less experienced staff
- Ensuring that they are suitably dressed in accordance with Company dress code and that any personal protective clothing provided is correctly worn as directed by SOP’s, Hazard Data Sheet or COSHH Assessment sheets. To include the wearing of specialist clean room gowning whilst working in a controlled/graded pharmaceutical cleanroom
- All staff will be regularly assessed on their knowledge, skills and behaviour, and application of all aspects of the job description, in line with the Trust’s Achievement Review (AR) process
Information Technology and Administrative Duties
- To enter accurately any appropriate data required on batch documentation, complete necessary documentation and to take signatory responsibility for key events where suitably trained and authorised to do so
- The Cleanroom Line Technician is responsible and accountable for the quality of the task or process that they are performing; they are responsible on completion of satisfactory training for the set-up, entry of data to computerised systems and operation of complex equipment
- To assist and take appropriate action in the investigation of corrective action and deviation documents. To accurately enter production details in Q-Pulse (Electronic Quality Management System) and manage directed actions as required
- To participate in validation studies, collect and assess technical data, read, understand and assess technical manuals