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S.Two
,
Derby, Derbyshire
Quality Officer
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Salary: £23k - 28k per year |
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Overview
Quality Officer Duration: 12 months Pay Rate: £11.79 - £14.38 per hour (£23-28k equivalent) Hours of work: 37.5 Mon-Fri 8am-4pm Hours of duty: 37.5 hours per week worked as shifts of 7.5hrs between 6am and 10pm (unpaid 30 minute lunch break) overtime/ weekends as required Job Purpose: v Participate in the GMP Quality Compliance team activities on site v Participate in the operation of the Quality Management System (QMS) v Manage and participate in the GMP investigation processes v To support the entry and analysis of quality data v Support the QA Laboratory Manager Accountabilities & Activities: To participate in the investigation process for environmental monitoring non-conformances and support the compounding team in any further actions required as a result of the investigation. Analyse microbiological data and non-conformance’s, escalating the severity where necessary. Identifying trends, employing root cause analysis (as appropriate) to propose and implement corrective and preventative actions where required. Analysis and preparation of environmental monitoring data into a report on a monthly basis, presenting the report at the EMM. Manage and maintain the GMP investigation processes, ensuring investigations are appropriately documented and completed within documented timescales. Support SME’s in the investigation of non-conformances and complaints, including root cause analysis Facilitate timely closures of CAPAs and review for effectiveness Participate in the operation of company quality systems including document control, auditing, supplier and customer complaints, supplier approvals, non-conformance management, CAPA management, risk assessments and change control. Supply monthly quality metrics for review in GMP managements meetings and reports Assist in the analysis and preparation of GMP non-conformance data into a report on a monthly basis To review and write work instructions. To aid the QA Laboratory Manager to ensure that all necessary testing, validations and other QA checks are carried out as required by our GMP Manufacturing licence. Ensure manufacturing processes meet appropriate quality standards. To work closely with the Site Lead and other LPCH personnel to ensure efficient communication channels and therefore the effective implementation of any corrective and preventative actions. To provide advice on QA related matters to Production and other departments To attend meetings or training based on other LPCH sites, when required and maintain regular and open communication with the QA Manager at all times To perform any other duties as required by the QA Manager Essential skills: Experience working in a GMP environment Experience working in QA/ QC Competent in the use of Microsoft Word™ and Excel™ Eye for detail Ideal skills: Competent in data analysis Effective written and verbal communicator Excellent attention to detail Ability to focus and meet tight deadlines Excellent problem solving/ investigational skills Experience of risk assessments and root cause analysis Desirable: Experience working in Aseptic Manufacture Experience working in a microbiology Laboratory Experience of risk assessments and root cause analysis Behaviours: Self starter, able to work on own initiative Quick learner Able to work cross functionally, interact with all types of people at all levels Qualifications, Training & Experience: Experience of working within QA in a GMP environment Competent in data analysis Experience of working within a GMP QMS and awareness of GMP regulatory requirements Experience of aseptic production & practical microbiology Judgement Skills: To identify hazards within the manufacturing process discussing the detail with the Senior QA and compounding staff for them to take action To identify day to day problems in the running of the QMS, informing senior QA staff for them to take action Freedom of Action: To initiate/manage change of procedures and processes within the guidelines of the MHRA Rules and Guidance for Pharmaceutical Manufacturers and Distributers, taking GMP into consideration with the approval of the QA Manager. Environment: The jobholder will be expected to work to both GMP standards, Some aspects of the role require repetition and great concentration. Unpredictable workload/balancing accuracy with deadlines, may sometimes lead to jobholder feeling pressurised