Senior Analytical Laboratory Manager - Pharma

    Toronto, ON, Canada
    • Degree with 7+ years experience in a pharma GMP environment
    • Experience in analytical development/ analysis of pharmaceutical products
    • Strong communication with experience working with external clients

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    SENIOR ANALYTICAL LABORATORY MANAGER - PHARMA

    Responsibilities:

    • Work with clients directly for day to day laboratory work, negotiated deliverables and complaints
    • Understand client needs and organize lab to ensure expectations are met
    • Implement new programs, tests, methods, instrumentation, and procedures by investigating alternatives
    • Ensure calibration and maintenance is performed.
    • Ensure compliance with current GMP requirements
    • Draft, review and have executed all analytical methods; method validations and method technology transfer studies
    • Review investigation and documentation of all laboratory OOS occurrences
    • Review COAs and approve validation protocols
    • Review and have executed all analytical methods; method validations and method technology transfer studies
    • Write or have written required SOPs and work instructions related to laboratory operation
    • Ensure GMP training is provided
    • Implement CAPA when initiated to include investigation, root cause analysis, corrective and preventative actions and documentation
    • Facilitate internal audits/customer/regulatory audits; and evaluate and implement effective corrective actions
    • Maintain laboratory staff by recruiting, selecting, orienting, and training employees
    • Host GMP audits from clients and regulatory agencies such as Health Canada
    • Oversee supervisors and group leaders such that a strict adherence to a defined hierarchy is maintained
    • Evaluate the abilities and performance of subordinates, mentoring and setting appropriate individual goals

    Requirements:

    • B.Sc. or higher with 7+ years’ experience supervising a pharmaceutical laboratory
    • Effective communicator with the ability to lead audits and experience in communicating directly with external clients
    • A strong working knowledge of regulatory requirements
    • A thorough understanding of laboratory safety requirements, MSDS’s and WHMIS
    • A thorough understanding of analytical chemistry and chemical instrumentation, including HPLC, GC, and other common pharmaceutical laboratory instrumentation.
    • Experience with raw material, finished product, and in-process testing, along with method development, validation, and tech transfer 
    • Considerable working knowledge of the methods, materials, and techniques used in laboratory work
    • Ability to manage and schedule the work of others

    Category: Biotechnology & Pharmaceutical

    Reference ID: CA7677BM001459

    Date Posted: 08/11/2019

    Shortcut: http://jobs.en.kellyservices.ca/XN2qZE

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