• Cleaning Validation Chemist at GlaxoSmithKline Plc (GSK)

  • Posted on: 25 July, 2017 Deadline: Not Specified
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  • We are a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of pharmaceuticals, vaccines and consumer healthcare. As one of the few healthcare companies researching both medicines and vaccines for the World Health Organization’s three priority diseases – HIV/AIDS, tuberculosis and malaria, we are very proud to have developed some of the leading global medicines in these fields. Our product portfolio also includes a range of consumer brands, many of which are household names around the world, including Sensodyne, Aquafresh, Horlicks, Panadol and Tums. Specialties Pharmaceutical products, Vaccines, Consumer healthcare products
     

    Cleaning Validation Chemist

     

    Basic Qualifications

    School: Grade 12

    Post School

    • Graduate qualification (or equivalent experience) in a scientific discipline.
    • BSc in chemistry or National Diploma in analytical chemistry.

    Experience

    • Good problem solving and analytical reasoning skills.
    • Good understanding of key analytical techniques (wet chemistry, spectrophotometry, chromatography)
    • Thorough understanding of GMP, safety and other GSK regulatory requirements.
    • Understand the manufacturing and testing processes for drug substances and intermediates.
    • Well developed verbal, numeric and presentation skills, computer literacy, competent in Microsoft packages.
    • Knowledge of specialist IT systems for laboratories, e.g. Empower 3, at least 3 years experience

    Details

    Preferred qualifications:

    Job Purpose

    Tests compliance of products on stability programmes to specification using various analytical techniques.

    Performs peer review for analytical results.

    High analytical / product complexity.

    Essential Job Responsibilities

    High range of experience and technical expertise required.

    • Test products on Stability programs according to Protocols.
    • Analyses a large range of product types – tablets, capsules, creams, ointments, creams, liquids, suppositories, pastes and powders
    • Develops Analytical Methods using acquired knowledge under direction of Manager/Cell leader.
    • Validates analytical methods according to protocols.
    • Prepares analytical method validation protocols.
    • Carries out analytical method transfers as per protocols.
    • Tests samples for Process Validation and Cleaning Validation as per Protocols.
    • Performs `Peer Review’ of analytical data as required.
    • Implements the OOS procedure for problematic results.
    • Applies Good Laboratory Practice principles, 6S and EHS standards.
    • Analyses QC product samples as requested by Manager/Cell leader.
    • Partakes in continuous improvement activities – Advocate projects.
    • Performs L1 audits
    • Closes out CAPAs, NCs and CCRs.

    Compliance GLP & QMS

    Complies with the requirements of Good Laboratory Practice and the requirements of the applicable GSK QMS Policies.

    Ehs

    Complies with EHS standards and guidelines and Site EHS SOPs.

    Complies with SOPs wrt safe use of chemicals/reagents, glassware, analytical procedures and the use of PPE.

    Operational Excellence

    Partakes in continuous improvement activities to reduce costs, increase productivity and improve quality.

    Participates in, projects to continually improve processes – LeanLab, OE and Leansigma methodology

    Method of Application

    Interested and qualified? Go to GlaxoSmithKline Plc (GSK) career website on careers.peopleclick.com to apply

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