To provide technical expertise to assist in the analytical testing on finished product & raw materials using the correct procedures in order to comply with GMP, Health and Safety, SOP's and environmental and regulatory requirements while ensuring we meet our customer's needs. This role also provides support as and when required to the Quality control Laboratory Manager/Designee.
ResponsibilitiesMaintain and follow all relevant Standard Operating Procedures (SOP's).Adherence to the existing methods with reference to pharmacopoeia's, specifications, regulations and industry standards.Adherence to regulatory and industry compliance and data integrity expectations.Displays technical competency and full understanding of methods and equipment relating to the following areas: HPLC, UPLC, GC, IR, UV, ICP, particle size, dissolution & physical testing.Full analysis of raw materials in a timely manner using appropriate analytical techniques with limited analyst related OOS.Full analysis of finished product (Spot on solution pipettes) in a timely manner using appropriate analytical techniques with limited analyst related OOS.Full analysis of contract-manufactured products in accordance with customer specifications with limited analyst related OOS.Incoming inspection of foils, labels, bulk finished goods.Calibration and maintenance of laboratory equipment as per calibration procedures.To support the laboratory testing schedule in order to achieve an efficient QC system and Customer Service level of >95%.To maintain all laboratory logbooks, notebooks & associated documentation to GLP.Liaise with team leader/supervisor & production so that timely reporting of results is achieved.Ensure timely feedback of all queries as appropriate.To bring to the notice of the team leader/supervisor any discrepancies, deviations or nonconformances in testing or work practice.Display ability and follow up on Corrective Actions.Sending out samples for external analysis when requested.Participating in internal/External Audits.Liaising with external suppliers/vendors in relation to QC consumables.Ensure existing quality procedures are followed and where appropriate suggestions/change control forms are prepared so that the quality system will be continuously improved.To adhere to any agreed internal laboratory rota tasks.Training of new personnel in the use of instrumentation & methods used within the QC Laboratory Function.To complete OOS Investigations and follow up on Corrective action.Adherence to laboratory safety measures at all times highlighting areas for improvement.Ensuring that laboratory is kept tidy and that GLP/GMP standards are adhered to at all times.Any other duties assigned by QC Manager.If decided appropriate it may be decided to amend/update any of the above responsibilities.Qualifications & ExperienceDegree in Science Discipline or EquivalentMinimum of 2+ years of experience within the pharmaceutical industry
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