Engineering Compliance Lead

Basic qualifications:

  • Bachelors Degree in engineering
  • 3 years experience in engineering or EHS/Compliance function, preferably in the pharmaceutical, petroleum, or chemical manufacturing industries.
  • Organizational, communication and influencing skills
  • Knowledge of cGMP, OSHA, NEC and EPA regulations
  • Experience in Failure Analysis, Root Cause Analysis methods and FMEA/FMEACA
  • Working knowledge of six sigma and lean manufacturing

Preferred qualifications:

  • Masters Degree in Engineering
  • 2 years experience in GMP environment
  • 1 year experience in a Compliance role with auditing responsibilities

Details:

The Compliance Team Leader position exists to extend the scope and effectiveness of site compliance program.

The Engineering Compliance Lead will be responsible for driving the Memphis compliance Strategy for Engineering taking direction from the Engineering Director. The role will be responsible for all engineering deviations, investigations, risk management and compliance to global Engineering standards and blue-chips.

Key Responsibilities:

  • The Engineering Compliance Lead must create an increased alignment with the GSK Quality Management System and Safety requirements for the manufacture of OTC Drugs and Medical Devices.
  • Manage the Process Safety program and Machinery safety program for the site
  • Manage all corporate GSK Bluechip compliance programs –TP13, GES, Asbestos, Legionella, Engineering Alerts
  • This role will oversee Level 1 auditing process, manage RMS for engineering, and support routine review and update of departmental SOPs and CSPs.
  • This role will be responsible for the coordination of training, presentation of metrics to area managers, performance/competency assessments and retraining to ensure all associates are fully trained.
  • Provide a safe and lean operating environment by complying with all essential statutory and corporate requirements.
  • Responsible for ensuring that engineering meet all statutory requirements and are carried out within the GSK safety, environmental and GMP requirements.
  • Ensure audit readiness by complying with effective standards, regulatory/statutory and cGMP requirement to prevent compliance observations.
  • Carrying out safety assessments for modifications to equipment

Contact information:

You may apply for this position online by selecting the Apply now button.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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