We are seeking to appoint a Pharmacy Production Systems Technician to join our dedicated team at our clinic in Leeds, West Yorkshire and inviting internal applications. The focus of this role: Assist with managing the Facility Management System and associated hardware. Assist with the management of production equipment. Assist with the management of the Quality Management System and the associated Technical Documentation. Experience in GMP environments. Experience or knowledge of equipment and system or process management and validation. Experience of writing Technical Documents Responsibilities Working with the Pharmacy Production Manager on a daily basis to ensure the production equipment, systems and technical documentation are GMP compliant. Ensure that scheduled equipment calibration, qualification and validation tasks are completed on time and to procedure. Ensuring that storage conditions of Investigational Medicinal Product / commercial and comparator are maintained (fridge/freezer/ambient) Investigate and report any excursions regarding storage of study drug material and contact the sponsor. To maintain documentation of storage conditions and resolve production issues. Involved in preparing doses (sterile / non-sterile) Involved in carry out in-process checking of doses (sterile / non-sterile) Involved in supervising and organising day to day workload of the Production Team and delegate tasks as appropriate Participate and lead in the training of staff To ensure that production documentation is completed to ensure complete accountability of study material and investigate discrepancies. To ensure that appropriate measures are taken that Investigational Medicinal Product / commercial and comparator are kept at the appropriate storage conditions. To assist with internal audits, self- inspections, and regulatory inspections as required. Assisting with production documentation; un-blinded and blinded dispensing/assembly or manufacture of medication/IMP/nIMP and supply/resupply. To ensure that all processes and procedures are GMP compliant. Ensure quality events are raised in a timely manner. Assisting in client monitoring visits. Help generate and update GMP SOP’s when necessary. To support and guide Production Assistants. To deputise in the absence of the Pharmacy Production Technician Report and take direction from the Production Manager to ensure service levels are maintained and the unit functions appropriately and safety. To complete broth validations and end of session media fills as per schedule. To perform all aspects of validations, performance qualifications and study dry runs. Free onsite parking Health Insurance 25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years' service) Your birthday off work Please email [email protected] should you require any special arrangements or reasonable adjustments to be made throughout this selection process. This will enable us to accommodate your request as necessary.