Hikma Pharmaceuticals USA Inc.

  • Supervisor, Chemistry

    Job Location US-NJ-Cherry Hill
    Posted Date 2 weeks ago(10/9/2018 3:44 PM)
    Job ID
    2018-4703
    Job Function
    Quality
    Shift
    Cherry Hill First Shift
  • Overview

    Supervise, plan, organize, direct and evaluate the activities of the Chemistry Laboratory. Responsible for daily operation and control of work flow. Implement and enforce testing standards and policies and ensure quality and regulatory compliance. Supervise laboratory safety measures. Assist lab personnel, evaluate and enhance performance of Quality Laboratory Associates and QA inspectors. Prepare quality reports on test results, if necessary.

    Responsibilities

    1. Ensure completion of all testing, including special project/protocol testing in a timely and appropriate manner.
    2. Assist in implementing quality and regulatory requirements (e.g., FDA, GLP, cGMP, USP and Ph. Eur. guidelines), and ensure compliance with testing SOPs and specifications. Monitor the testing techniques and accuracy of all records and documentation that is done in the lab.
    3. Participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support. Review and approve process validation, cleaning validation and raw material qualification protocols and reports.
    4. Maintain expenses at or below budget for the lab.
    5. Assure a safe and non-discriminatory working environment for employees.
    6. Ensure employees are properly trained and performing tasks according to company policies and procedures. Make appropriate staffing recommendations. Evaluate performance via performance appraisals and ensure employees have career development plans.
    7. Prepare, review and revise, as required, SOPs and specifications. Write memos, reports, protocols, CPAs and other appropriate documentation for proper functioning of the lab operation.
    8. Assure equipment maintenance and calibration, and internal audits are performed on schedule. Prepare, review and approve protocols and associated reports and audit responses.
    9. Conduct audits for documentation, cGMP and Safety to maintain compliance.
    10. Conduct laboratory investigations, troubleshoot and resolve instrument and method problems. Review and approve protocols and reports. Prepare monthly reports and submit to upper management.
    11. Recommend instrumentation purchases and upgrades for the laboratory that ensures optimum lab performance. Troubleshoot and resolve instrument problems. Stay current in the field of lab instrumentation and methodology.

    Qualifications

     

    1. Must know operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements pertinent to pharmaceutical manufacturing labs.
    2. Must possess excellent supervisory and interpersonal skills and be able to communicate with subordinates, peers and managers.
    3. Ability to lead projects with minimum supervision, good knowledge of “Out-of-Specifications” management process, technical problem solving skills.

     

    Bachelor Degree in Chemistry, or biological science with Analytical Chemistry or Laboratory coursework. Five to seven years of experience in healthcare industry.

     

     

     

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