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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 guidelines
- To prepare stability protocols as per ICH guidelines
- To develop test methods using HPLC for assay and related substances
- To validate test methods for assay & related substances
- To 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 sites
- To undertake scientific and technical review of formulation compositions to meet regulatory and safety requirements.
- To understand bioequivalence work & regulatory pathways
- To 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 Practice
- Maintain detailed and accurate records of all work undertaken
- Accurate 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 required
- Ensure routine cleaning and general laboratory maintenance duties as require
- Maintain the confidentiality of company’s formulations and product developmental activities
- To support the Head of R & D and carry out all other duties as may be assigned from time to time
- To 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)
Experience:
- Analytical Chemistry and Instrumentation: 3 years (required)
Language:
- Fluent English (required)
Work authorisation:
- United Kingdom (required)
Location:
- Birmingham, West Midlands (required)
- Work Location: In person
