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Job summary The candidate will be working within a Quality Control Laboratory based within the Pharmacy Production Unit at the Royal Victoria Infirmary.The role involves a mix of traditional Quality Control laboratory techniques and also supporting the Pharmaceutical Quality System such as writing QC worksheets, Standard Operating Procedures and change controls. The role will lead to the person acting as a releasing officer for the MHRA MS17163 licence held by Newcastle Specials for the release of 'Specials' manufactured by the Pharmacy Production UnitThe laboratory equipment includes HPLC, FTIR, auto titrators, pH meter, conductivity meter, refractometer, melting point etc. Test methods are used to support product testing for release for patient use and stability studies to support expiry allocation of current products and also allocate expiry's for new products. Interview date: 15th May 202437 hours 30 minutes /weekYou will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy. Main duties of the job Liaises with Pharmacy Production personnel Operations Manager, production pharmacists, Team Leaders and Specialist Production Technicians also dispensary staff and pharmacy stores staff and on a daily basis.Performs checks on ingredients for all laboratory reagents.Monitors temperature records to ensure excursions reported immediately to the appropriate member of staff.Observing and judging work practices to decide when documentation and procedures require updating.Needs to use skills in chemical analysis to develop and validate new methods for product assay and stability as required by local, national and international guidelines.Need to interpret the results of any validation work carried out to ensure that they comply with the appropriate protocols and advise the Laboratory Manager accordingly.Needs to be able to interpret equipment validation results in order to release equipment into use and produce the appropriate Standard Operating Procedures for final approval by the Laboratory Manager or Trust Quality Controller.Needs to be able to interpret and check Suppliers Certificates of Analysis and Certificates of Conformity to ensure compliance with the appropriate Pharmacopoeial Monographs.Needs to understand the QC worksheets and related procedures to investigate out of specification results as required by regulatory requirements. To produce hypothesis testing protocols for investigatory work. About us Newcastle Hospitals NHS Foundation Trust is one of the busiest, largest and most successful teaching NHS foundation trusts in the country, we have around 16,000 staff and an annual income of £1 billion.We have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally.We're also proud to be the second largest provider of specialised services in the country. This means we support people with a range of rare and complex medical, surgical and neurological conditions, cancers and genetic orders.Our staff oversee around 2 million patients 'contacts' each year, delivering high standards of healthcare.Please see attached information on what Staff Benefits we have to offer at our Trust.We are committed to promoting equality and diversity and recognise the benefit in providing an inclusive environment. We value and respect the diversity of our employees and aim to recruit a workforce which reflects the communities we serve, and is equipped to deliver the best service to our patients. We welcome all applications irrespective of people's race, disability, gender, sexual orientation, religion or belief, age, gender identity, marriage and civil partnership, pregnancy and maternity and in particular those from under- represented groups. Job description Job responsibilities To undertake the range of laboratory and other duties necessary to ensure the pharmaceutical Quality Control service operates in an efficient, safe and effective manner. To operate and maintain a range of equipment to ensure safe and suitable for use. Understanding and following the regulatory requirements for the introduction of new equipment. To generate and follow laboratory procedures and worksheets to ensure consistent methodology. To undertake the development and validation of stability indicating analytical methods for current and new medicinal products that are manufactured in the Pharmacy Production Unit and for outside companies that we are contracted to perform such work. To plan stability test points and ensure all products are assessed for on-going stability. To undertake laboratory investigations in the event of out of specifications in line with current regulatory guidelines. To initiate microbiological investigations in the event of environmental excursions. To generate when required and also be involved in quality control assessment of change controls for the pharmacy production unit and quality control. To release Water of Injection in bulk daily following plant and equipment checks. The role will lead to the person acting as releasing officer for the MHRA MS17163 licence held by Newcastle Specials for the release of Specials and to deputise for the Laboratory Manager other quality control duties as required following the completion of an appropriate formal training course that will provide the person with the required body of knowledge to undertake the activities associated with being an authorised releasing officer. The role may also lead to training and registration as a QC(MGPS),performing tests on medical gases as required under HTM 02. As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you. Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS method of payment is a salary deduction from your first months pay. Person Specification KNOWLEDGE Essential Good working knowledge of organic, inorganic and physical chemistry. Good knowledge of analytical techniques used in pharmaceutical quality control. Familiarity with laboratory safety requirements. HSE, COSHH Desirable Some knowledge of microbiology, preservatives and sterilisation SKILLS Essential Practical ability to carry out careful and accurate chemical analyses using both traditional and instrumental methods and an awareness of the limitations of different techniques. Ability to develop new analytical methods. Good keyboard and general IT skills Good communication, interpersonal and organisational skills Ability to support the Laboratory Manager in the training of all grades of staff and introducingstudents into the Quality Control environment. Desirable Proficient in use and maintenance of laboratory instruments including FTIR, UV, HPLC. EXPERIENCE Essential Analytical laboratory experience Desirable Experience in pharmaceutical analysis and/or quality control QUALIFICATIONS Essential Degree or equivalent in a scientific subject Chemistry or Pharmacy. Desirable Postgraduate qualification in analytical chemistry or quality control. Ability to register with the Royal Society of Chemistry or equivalent