Hikma Pharmaceuticals USA Inc.

  • MIR SCIENTIST

    Job Location US-NJ-Cherry Hill
    Posted Date 2 weeks ago(8/3/2018 8:50 AM)
    Job ID
    2018-4698
    Job Function
    Manufacturing
    Shift
    1st
  • Overview

    Review investigations for quality related events triggered through the manufacturing process. Provide feedback to the investigation writer on the quality of the report with emphasis on compliance to SOP’s and cGMP.

     

    Individual to be a focal point for managing the event process to assure timeliness in completion of effective and concise investigations. Provides daily, weekly and monthly reports on key performance indicators or metrics related to the process.

     

    Must be the subject matter expert in the auditing/investigative process and provide the necessary leadership to assure continuous improvement in the mitigation of events associated with the manufacturing process.

    Responsibilities

    • Review, revise and approve investigations in a timely manner to ensure compliance and timely product release and internal deadlines are met
    • Individual to provide direction for process improvements or preventative measures to avoid or minimize process deviations consistent with business requirements.
    • Lead Manufacturing Investigation Report (MIR) Review Board meeting
    • Gather, assess, and distribute daily, weekly and monthly metrics.
    • Perform QA Investigations or other assigned investigations as required.
    • Manages the electronic database and ensures that investigations are processed in timely manner.
    • Maintain the electronic file of completed MIRs.
    • Performs follow-up audits to confirm corrective and preventive action is effective according to schedules set.
    • Trains new auditors on the investigation process.
    • Revise and train individuals on the SOP's relating to the investigation process. Participates in the development and delivery of training/refresher courses in quality systems and or GMP regulations and requirements and consultation as necessary.
    • Supports management during external inspections and participates in the management of external inspections as required.
    • Participate on Teams or Special Projects as assigned

    Qualifications

    Able to read, write, speak and understand English. Must have excellent verbal and written communication skills, sound judgment and analytical skills to enable assessment of risk. Resourceful, self-reliant, self-motivated and confident. Able to work independently and be flexible to changing priorities. Strong personal computer skills. Must have excellent teamwork and organizational skills.

     

    Education and/or Experience:

     

    Bachelor's degree with experience in a technical or scientific (Pharmaceutical Manufacturing) discipline. Five plus years experience in the areas of GMP regulations. Previous auditing experience is a plus

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