Job Title: Production Operator Department Production Reports to: Production Lead Principal Contacts: Quality Control, Planning, Engineering, Quality Assurance, Warehouse, Procurement Location: Romford Job Level: 6 Job Purpose To work as part of a team that produce high quality pharmaceutical products with a focus on the treatment of pain, addiction and critical care. Main Responsibilities & Duties As part of a team, work towards daily targets to meet the weekly production schedule utilising specialist pharmaceutical equipment Ensure that all activities within the area are undertaken to established standards of Good Manufacturing Practice (cGMP) Complete batch manufacturing records accurately, neatly and maintaining integrity of data recorded at all times Follow GMP working instructions and guidelines to ensure the product is produced to the right quality Work closely with the Engineering team in the event of machine breakdowns Working closely together as a team to ensure batch-to-batch tasks are completed efficiently to minimise downtime Perform quality control checks throughout the process to ensure product and patient safety Undertake gowning process to enter the cleanroom safely and to GMP Regulations Preparing the area & sanitising equipment for use in the production of sterile or aseptic products Maintaining the cleanroom environment by following strict guidelines and SOP's Combine pharmaceutical ingredients together to make a bulk solution ready for filling Using high-tech machinery, fill the bulk solution in to syringes or ampoules ready for sterilisation Depending on product type, sterilise the product using specialist equipment (autoclave) Under the guidance of the Microbiology team, undertake environmental monitoring tasks on a routine basis Additional Responsibilities Where GxP data is generated, ensure that the principles of Data Integrity are adhered to Be an active team member on continuous improvement projects bringing about improvements in working practices to eliminate waste and reduce variation in the area Work with line management to perform various risk assessments within the production area to ensure a safe working environment is maintained for all staff Actively support management in self-Inspections, action planning and follow-up. Working with the management team during investigations into batch losses to come up with solutions and improvements to prevent reoccurrences Reporting of any deviations to your process so Management can ensure batch integrity at the earliest possible opportunity Assisting in the development of self and peers For more experienced Operators, deputise for Shift Supervisor if necessary Represent the department in meetings where required Requirements Essential Desirable Educational Level Educated to GCSE (or equivalent) level Experience Experience of working within a process driven/structured environment Experience of Microsoft packages (Word, Excel, Outlook) Experience of operating machinery Experience working in a pharmaceutical manufacturing environment Experience of using SAP Qualifications Grade A-C (or equivalent) GCSE in Maths and English GCSE A-C (or equivalent) in Science or Engineering Knowledge Knowledge of health and safety standards required in a production environment A good understanding of manual handling practices Good knowledge of written and spoken English Good understanding of cGMP within a manufacturing environment Skills & Personal Qualitie s Skills Strong communicator Excellent customer service skills Strong numeracy and literacy skills High attention to detail Excellent time management skills Good level of computer literacy Able to follow written and oral instructions Abe to perform manual handling within HSE guidelines Personal qualities Methodical approach Self-starter and approachable Flexible and diligent Hardworking and positive attitude Team player Adaptable and willing to learn Able to wear restrictive PPE for long periods of time Technically minded, able to see beyond a process