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  • Posted: Jun 23, 2022
    Deadline: Not specified
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  • Aspen has a proud heritage dating back more than 160 years and is committed to sustaining life and promoting healthcare through increasing access to its high quality affordable medicines and products. Aspen has a market capitalisation of approximately US$10 billion, is the largest pharmaceutical company listed on the JSE Limited (share code: APN) and rank...
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    Laboratory Analytical Scientist (East London)

    Overview

    • Lead scientific investigations in QC Lab
    • Develop systems and processes for conducting investigations within GMP requirements
    • Evaluate analytical equipment and techniques
    • Reduce on Laboratory OOS with effective Preventative Actions
    • Improve efficiency by reducing repeats
    • Trend and analyse OOS data to identify improvements

    Requirements

    Responsibilities

    Planning and Operational Support

    • Provide technical and operational input on operational planning of the unit and on the prioritisation of objectives
    • Determine, request and allocate assets and resources for fulfilment of work objectives, and monitor its use
    • Apply advanced understanding of area of specialisation
    • Analyse concepts and suggest streamlined procedures
    • Identify training needs of QC staff 

    Deviations Investigations

    • Lead all scientific investigations within the QC Lab
    • Lead the identification, investigation and reporting of OOSs, deviations, and other nonconformities according to GMP requirement and SOPs
    • Identify OOS data trends to establish any systematic issues in process, testing, calibration or maintenance
    • Implement plans to reduce and mitigate OOSs
    • Perform impact and risk assessments of CAPA plans on process compliance 

    Reporting and Record-Keeping

    • Compile complex reports and documents according to GMP requirements
    • Update records and systems as required
    • Ensure that recordkeeping complies with legal requirements
    • Monitor and control access to databases in area of responsibility

    Skills Required

    Background/experience

    • Post Graduate Degree/ Diploma in Chemistry/ Analytical Chemistry with 2 to 4 years’ related experience
    • Experience in quantitative and instrumental analysis in QC laboratory environment

    Specific job skills

    • Extensive experience in scientific principles and laboratory techniques and methodologies
    • Scientific report writing skills
    • Understanding of pharmaceutical manufacturing, standards and compliance requirements
    • Ability to interpret and implement policies, processes and objectives

    Competencies

    • Information Gathering
    • Interrogating Information
    • Offering Insights

     Accountability & Decision Rights 

    • Demonstrate initiative and apply advanced concepts
    • Exercise interpersonal, communication, training and problem-solving skills to optimise team performance
    • Integrate resources for an area
    • Escalate highly complex problems or out-of-policy issues

    Decisions relating to:

    • Technical approach for project components, often in ambiguous situations, requiring advanced analytical skill, training and/ or education
    • Establishing own work priorities and timelines
    • Interpretation of policies, standards, requirements and approaches

     Deliverables

    • Deviations, OOSs and other nonconformities investigated and reported
    • Laboratory OOS reduced
    • Investigations performed according to regulation and standards
    • All deviations reported
    • Plans implemented to address, reduce and mitigate deficiencies
    • Record-keeping complies with legal requirements
    • Data integrity and access to systems controlled

    Innovation, Creativity & Problem solving

    • Identify and lead opportunities to enhance staff productivity and operational processes, tools and services
    • Demonstrates creativity and initiative to problem solve and improve results
    • Apply advanced interpersonal and problem-solving skills
    • Regularly contribute actionable ideas

    Method of Application

    Interested and qualified? Go to Aspen Pharma Group on aspen.mcidirecthire.com to apply

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