Quality Analyst

Kinetic Recruitment are currently looking for a Quality Analyst, to work for an international Pharmaceutical company, based within the Runcorn area. Annual Salary: £30,060 18 months from start 25 Days Annual Leave (pro rata) plus Bank Holidays 19% Shift allowance applicable Shift Pattern: 2 week shift rotation. Monday, Tuesday, Friday, Saturday and Sunday. Wednesday and Thursday. 06:00am to 18:00pm. Purpose of Role: To provide data through microbiological testing regimes, from which confidence in the sterility of the finished product can be founded. Provide technical support to production on microbiological / hygiene and contamination control issues. Key Results Areas: 1. Perform Environmental monitoring within Grade B - D clean rooms and filling machines at the appropriate frequency. 2. Undertake testing of key components. This includes testing of in-process samples, Raw Materials and filled product by various techniques such as T.V.A.C, Bacterial Endotoxin and Sterility testing. All testing to be completed using good Aseptic technique. Results entered into the Microbiology Database and trended where necessary. Anomalous results to be communicated to the Team leader. 3. Undertake testing of Utility services (Water for Injection, Compressed Air, Room Particle counting). 4. Support validation work of above techniques, when required. 5. Time lines to meet Departmental KPI's, monitoring high RFT (Right First Time) records. 6. Bacterial Identification, Control of type cultures and in house Media QC. Media preparation and use of the autoclave. 7. Documentation. All documentation must be completed in real time and in full. Procedural review and updates. Compile batch summary reports ready for batch release. Compile Quality department reports to solve microbiological issues. Complete Performance Qualification documentation to the required standard. Responsible for upkeep of own training records and progressing training in line with Business needs. 8. Provide advice to the manufacturing department on microbial, hygiene and contamination control. Feedback from other departments 9. Consistently demonstrate required behaviours (teamwork, attention to detail etc) Areas of Impact Affecting the Job: - Testing to be carried out on both intermediate and finished product to support each product batch manufactured. This will include microbiological testing and reading of Media studies completed on filling machines. Utilities are continually monitored to demonstrate compliance. - All necessary testing, both directly and indirectly associated with each product batch is completed within the target time. 100% Sterility test pass rate with no false positives. - Environmental monitoring to be carried out in all clean areas when in use. Laboratory testing completed in real time. - Work within a team to ensure tasks are completed in a fast paced Laboratory, as coordinated by Seniors and Team Leader. All tasks supporting Sterility Assurance of Products and Medicines. - Planning, Organising and Controlling - Day to day tasks under the responsibility of the technician are to be planned and organised as directed by the Senior Microbiology Technicians or Team Leader. It is the job holder's responsibility to report delays or uncompleted tasks directly to their seniors. Knowledge, Skills and Abilities: - Able to communicate both orally and in the written format to personnel at all levels. - Thorough understanding of the need for quality which will be derived from the attention to detail. - Ideally computer literate and familiar with such programs as Word, Excel etc. - Organisation of required tasks, especially where priorities change - Excellent communication skills within team - Customer focus (internal and external), Teamwork, Initiative, Maximising performance - Preferably pharmaceutical knowledge and experience - A Degree qualified or HNC in Microbiology / Biological sciences + lab experience If you feel that you have what we need, then please do call Sophie on 01244 821737 or email your up to date CV to: [email protected] Kinetic plc is a Recruitment Consultancy with over 40 years of experience of delivering staffing solutions to the engineering, manufacturing and technical industries. Kinetic Plc treats all applications with a high degree of care, we review all submissions and will attempt to contact applicants who match the job profile. Those that do not meet the specification may not be contacted but their CV retained to be considered against future opportunities. IND1