Analytical Chemist
Title: Analytical Chemist - Reports to: Head of Research & Development JOB PURPOSE: To undertake analytical testing to develop new formulations and to establish stability of pharmaceutical finished products to support R & D department. CORE RESPONSIBILITIES: To perform analytical testing using typical pharmaceutical analytical instruments HPLC, UV spectrophotometer, FT-IR and Karl Fischer etc...To perform simple lab techniques to test density, viscosity, gravimetric testing etc...To qualify analytical instruments such as HPLC, UV, stability chambers.To write up product specifications as per ICH guidelinesTo prepare stability protocols as per ICH guidelinesTo develop test methods using HPLC for assay and related substancesTo validate test methods for assay & related substancesTo write up validation work results in reports.To support R & D formulation team for additional testing requirements.To undertake maintenance of relevant analytical instruments.To ensure the required initial and continuing training relating to work performed.To organise storage of raw material samples (APIs & excipients, finished products) & documentations such as Certificate of Analysis& MSDS and Calibration Certificates.To write up quality documentation such as SOPs, Quality and Training Manuals, Test Methods, specifications.To write technical reports on projects.To assist in technical transfer to commercial sitesTo undertake scientific and technical review of formulation compositions to meet regulatory and safety requirements.To understand bioequivalence work & regulatory pathwaysTo understand biowaivers and writing up justification reports.Work in a safe responsible manner at all times and towards the implementation of Good Laboratory Practice and Good Manufacturing PracticeMaintain detailed and accurate records of all work undertakenAccurate analysis and calculation of results, in line with written Protocols and Standard Operating Procedures of the company.Write internal and external reports as assigned by the Departmental head.Communicate progress of projects effectively to senior management as requiredEnsure routine cleaning and general laboratory maintenance duties as requireMaintain the confidentiality of company’s formulations and product developmental activitiesTo support the Head of R & D and carry out all other duties as may be assigned from time to timeTo work closely with Analytical scientists in development work. REQUISITE ACADEMIC QUALIFICATIONS, KNOWLEDGE BASE & WORK EXPERIENCE Graduate in Pharmaceutical Sciences/Chemical Sciences or equivalent.Experience in analytical chemistry and instrumentation of at least 3 years.To have knowledge of Quality Management Systems, documentations such as SOPs, qualification protocols & reports, method validation protocols and reports, starting material and finished product specifications, stability protocols and reports, Internal audits.To have knowledge of analytical instruments.To be a good team worker with good communication skills written and oral.To have undergone basic GMP course in order to have an appreciation of Quality Management Systems, documentations Site Master Files, SOPs, change control, premises, equipment, starting material and finished product specifications, production, release and QC testing, Environmental monitoring, Internal & External audits and Orange Guide Ability to commute/relocate: Birmingham, West Midlands: reliably commute or plan to relocate before starting work (required) Application question(s): Have you Undergone basic GMP course to have an appreciation of Quality Management Systems, documentations Site Master Files, SOPs, change control, premises, equipment, starting material and finished product specifications, production, release and QC testing, Environmental monitoring, Internal & External audits and Orange Guide? Education: Bachelor's (preferred) lGraduate in Pharmaceutical Sciences/Chemical Sciences or equivalent. NOTE: YOU MUST BE A UK RESIDENT Experience: Analytical Chemistry and Instrumentation: 3 years (required) AT A COMPANY IN THE UK Language: Fluent English (required) Work authorisation: United Kingdom (required) Location: Birmingham, West Midlands (required)Work Location: In person
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