Hikma Pharmaceuticals USA Inc.

  • Spec II Env Stor QC

    Job Location US-OH-Columbus
    Posted Date 2 weeks ago(11/29/2018 9:38 AM)
    Job ID
    2018-4944
    Job Function
    Quality
    Shift
    Columbus First Shift
  • Overview

    Maintain and Monitor Environmental Storage Areas (ESA) in accordance with Regulatory Commitments.  Provide maintenance and customer support for the LIMS Stability/Reserve Management. Review documentation required for sample studies and draft departmental policies and procedures.

    Responsibilities

    • Writes, revises, and reviews stability protocols in accordance with standard operating procedures and work instructions.
    •  Identifies and updates departmental work instructions and SOP’s.
    • Applies knowledge of cGMP, FDA regulations, SOPs, and work instructions to insure studies are started correctly and regulatory compliance is maintained. 
    • Utilizes most current processes to insure proper level of assignment of stability samples throughout the year.
    • Recognizes updates from the manufacturing processes to insure the correct studies are tested. 
    • Evaluates product updates as a result of the change management process, including packaging components, API’s, etc. 
    • Communicates with customers to assess their needs and timelines. 
    • Required computer knowledge must include the following to communicate with customers and to insure compliance.
    • Trackwise, EBR, SAP, Access, Word, Excel, QSDB, Labware, Veeva Vault, Record and SMS.
    • Keep up to date inventory on all studies using LIMS. 
    • Use Trackwise to identify launch products and annual reportable changes.
    • Use Trackwise to review and approve stability commitments and monitor for changes.
    • Plans and organizes the ESA technicians to assure appropriate laboratories receive sample on testing due dates. 
    • Coordinates destruction and reconciliation of non-class and class samples via LIMS 
    • Communicates data via electronic processes.  
    • Perform lifecycle maintenance for stability studies using LIMS and SAP.
    • Maintain Environmental Storage Areas within designated conditions through 24/7 monitoring using the stability monitoring system software (SMS).
    • Responds to chamber outage alarms 24/7 so that stability samples can be moved to safe locations so that commitments and compliance are upheld.
    • Review all deviations and excursions and record in SMS and the Quality System Database (QSDB) to stay in compliance and always be audit ready. 
    • Coordinate maintenance of chamber to keep them in working order. Including the issuance of work orders.
    •  Reviews or Approves the performance qualifications (PQ) and mapping on stability chambers so that qualifications   are up to date after completed by validation.
    •  Diagnose problems and/or develop technical solutions as necessary for studies, chamber conditions, or issues with LIMS.
    •  Review and evaluate capabilities of LIMS system for conformance to standards and additional improvements.
    •  Create validation test scripts for LIMS.
    •  Monitor Trackwise for system changes to Computer Systems Validation and review / Approve as needed.
    • Other duties as assigned.

    Qualifications

    Diploma Degree (science) and 3 years’ experience and/or Tech or Assoc degree and 5 years of Pharm. Experience and/or High School Diploma degree and 7 years of industry experience.

    Knowledge of cGMP, FDA/CFR21 regulatory guidance regarding storage chambers and stability studies is required.

    Previous experience in Laboratory setting is required.

    Ability to completing advanced troubleshooting of analytical problems.

    Demonstrated ability to follow procedures and maintain performance standards to support company goals and compliance with SOPs, cGMPs, GLPs, ICH, OSHA and USP.

    Must possess good written and oral communication skills to communicate clearly and concisely; knowledge of structure and content of the English language (the meaning and spelling of words, rules of composition, and grammar), the ability to read and understand information and ideas presented in writing and through spoken words and sentences, the ability to enter, transcribe, record, store, or maintain information in written or electronic form.

    Demonstrated teamwork skills - providing information and assistance to supervisors and co-workers in a collaborative manner which encourages trust, mutual respect, and shared purpose among team members. 

    Ability to be exact or highly accurate with attention to detail in performing duties.

    Strong planning and organizing skills to ensure commitments and deadlines are met

    Proficient experience with LIMS, QSDB, SAP, MS Word, Excel, Outlook, and/or PowerPoint required. 

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