Development Analyst - Pharmaceuticals

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Irfa******

  • United Kingdom 
  • Last Update: 27.11.2018 at 12:00

Job Type
Full Time
Start
ASAP
Duration
12 Month
Place
Runcorn, GB
Country
United Kingdom

Category


Regulatory, Quality and Clinical

Description


ResponsibilitiesPerform analysis on raw materials, components, in-process, finished product and stability samples, as per relevant analytical specifications and proceduresStatistical analysis and interpretation of data, and identification of out-of-trend and out-of-specification resultsComplete the investigation and root cause analysis of analytical issues, including OOS/OOT results and implementation of any associated CAPAs in line with site expectationsProvide technical support, guidance and training to colleagues as requiredAble to act as customer technical supportPreparation and review of GMP related documentation (analytical methods, SOPs, specifications, monographs, protocols, reports)Assist in day to day running of laboratory in order to implement priorities and workloads as indicated by the team leaderDevelopment of new analytical methods using Quality by Design principlesPerform validation of analytical methods including writing protocols and reportsComplete documentation associated with laboratory functions in line with GMPResponsible for ensuring that all working areas and surrounding areas are compliant to GLP, GMP, and are well kept and maintained.Issue regular progress updates to management and present appropriate information, as requested at scientific or project review meetingsAbility to raise change controls, deviations and other quality documentation, showing attention to detailMaintain a safe working environment within the laboratory, ensuring risk assessments and COSHH assessments are carried out on a routine basisMaintain a high quality standard within the laboratory, ensuring laboratory note books, log books and other documents are maintained to an acceptable standardAnalysis, write ups, workbooks and documentation right first timeAble to complete data confirmation, checks and reviewRequirementsDegree, Masters or PhD in Chemistry or an associated subjectExperience in working within a high throughput analytical laboratoryStrong technical knowledge and capability in analytical chemistry with strong emphasis on HPLC and GCExperience of MDI and DPI analytical testingProven ability to work collaboratively with others: maintaining excellent stakeholder communication whilst ensuring the primary needs of the business are met.Proven track record in the ability to demonstrate initiative and work with diverse groups to reach consensus.Communication skills with emphasis on the ability to impact and influence people without direct line authority

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