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Quality Engineer

  • Contractor
  • Branchville, NJ
  • I3INFOTEK
  • Prefferd visa: OPT
  • Posted 3 years ago – Accepting applications
Job Detail
  • Offerd Salary $ 30 - $ 40
  • Required Position 1 hire
  • Experience 5-6 Years Required
Job Description

Please forward your resumes with rate and contact number to hr@i3infotek.com & kalyan@i3infotek.com

 

Provide support to PR05 Quality systems elements such as: Deviations, Changes, Quality Plan, Management Review, GAP Assessment, Activity planning, Site Self Inspection program, Quality metrics, and Master Job descriptions. Sustain and improve the Global Record & Information Management System in PR05. Provide support for the proper retention of GMP documents in the site.
Sustain and support Quality documentation and activities related to audit readiness.

 

 

Job Requirement

Responsibilities:

1. Educate site about document management in compliance with Global Record & Information Management System requirements. Keep communication and support to Departmental Records and Information Management Stewards.

2. Maintain and improve applicable Quality SOP's, Quality Logbooks, and trainings.

  • Ensure Quality Master Job Descriptions be periodically reviewed and approved according to requirements.
  • Provide support to Quality systems such as Monthly Metrics, Quality Plan, Deviations, Changes, Activity planning, and Site Self inspection program.
  • Create GAP assessments records, provide Facilitator's training, maintain GAP assessment facilitator list updated, and provide support to assure compliance with the procedure and activities.
  • Give support as Trackwise power user.
  • Provide support in the document retrieval process prior and during internal/external audits.
  • Assist in the proper custody of GMP documentation.
  • Assist in audit readiness related activities.
  • GMP library back up

    • Compliance
    Complete the required compliance training such as "The Red Book; apply knowledge, principles, and requirements to daily work and in business relationships with customers, suppliers, employees, stakeholders, etc.

    Safety
    Comply with the requirements established in the Security Policy, Occupational Safety and Industrial Hygiene Policy, Standard Operational Procedures (SOPs) and Basic Safety Rules, including:

    • Comply with the safety goals and objectives of the organization
    • Monitor personal performance in the industrial health and safety area.
    • Notify and initiate actions to correct any hazard conditions/risks in my working area.
    • Actively participate in the safety trainings applicable to my area.
    • Notify Management of any emergency incident, register, and comply with the communications requirement.


    Environmental
    Use of all office supplies in an efficient manner.
    Make copies on both sides of the paper to minimize paper waste.
    Use the electronic mail system as possible to minimize paper waste.
    Turn off the lights and the equipment when not in use to save energy.
    Observe, promote and comply with EPA and internal environmental standards as appropriate

    Required skills
    Quality Logbooks Quality SOP's Deviations Management Review
     

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