Production Operator (RSC Filling

The RSC Filling department sits within the Respiratory Supply Chain (RSC) at the GSK Ware Manufacturing site and is responsible for performing a variety of tasks relating to manufacture of GSK's respiratory products. Specifically, you will set up and operate a range of filling machines (currently 'Mk2' and 'Mk3' platforms), to manufacture spools and test a continuous length of filled blister strip containing a blend of Active Pharmaceutical Ingredients (APIs) and lactose ready for assembly into respiratory inhaler devices.

• Set up batches (consisting of kegs of blend and reels of base and lid foil): booking materials on computer systems, physically bringing the batch materials on line, setting up batch information on equipment HMI's.
• Make adjustments to the filling process to ensure a consistent quality of filled strip production in compliance with the batch documentation, SOPs and WIs, and to minimise rejects in the process.
• During production, and with reference to SOPs and WI's, monitor machine reject alarms, equipment state and quality of strip produced and take appropriate actions to remedy or elevate any problems.
• Perform In-Process Control (IPC) checks on a routine basis, and take corrective action where results fall outside specification (as detailed in SOPs and batch documentation) to ensure consistent quality of manufactured strip.
• Perform all daily and weekly critical device checks to ensure the filling machine and ancillary equipment operate within specification to ensure consistent quality of manufactured strip.
• Perform batch reconciliations and complete all batch-related documentation accurately, including use of company Information Technology (IT) systems (including the 'Systems Applications & Products / Manufacturing Enterprise Resource Planning Solution' [M-ERP/M-ERP], Activplant, Aspen Info Plus
  21 (IP21), My Learning, Environmental Monitoring System (EMS), planning spreadsheets and team sites, Material Safety Data Sheets, WI's and SOPs). This includes processing material movement of finished strip to the Store 70 warehouse. The process of reconciliation ensures that all materials brought on line are accounted for at the end of the batch and prevents cross-contamination of subsequent batches.
• Dismantle, clean and reassemble the machine to required SOP standards and perform line clearances between batches to ensure there is no cross-contamination of product and/or materials to subsequent batches.
• When not operating a filling line, to act in a support role to ensure continuous production is maintained by covering operators' breaks; also re-supplying the filling lines with components and materials (including use of electric pallet trucks if trained); assisting with batch changes, cleaning and line clearance; assisting with training; taking part in departmental projects.
• Take on additional roles within the department, as agreed with the manager and in accordance with the area Team Plan. Additional roles in Filling department include Work place trainer, Document Author/Content Owner (SOP and/or Standard Work);
  Quality Management System (QMS) Reviewer;
  Safety Assessor (Noise, Manual Handling, Ergonomic, Control of Substances Hazardous to Health [COSHH]), back up stores role and Operator Plus (supporting Engineering related tasks).

This role will operate on the DANF - 24/5 Days & Nights  Full  (12-hour) shift pattern. This entails 2 or 3 shifts on (followed by 2 to 4 days off, depending on shift rota), and includes working night shifts.

• Relevant manufacturing/production experience (ideally knowledge of working in a Filling role obtained from a highly-regulated industry like the pharmaceutical industry).
• A good standard of numeracy and literacy is needed (eg; GCSE Mathematics & English or equivalent).
• Basic computer literacy., Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Lean Management, Manufacturing Processes, Problem Solving, Production Management, Quality Compliance, Regulatory Compliance, Risk Awareness

We are co-located with our R&D colleagues and recently opened a new, state-of-the-art oral solid dose facility  this…