Duties:

• Support the compliance team in implementation of business requirements around GxP needs.
• Provide support for issues related to equipment, systems or utilities having significant risk to the client operations.
• Conduct appropriate compliance internal audits on a regular and ad hoc basis.
• Support regulatory assessments by planning and preparation, and facing the auditor as requested.
• Control, monitor and complete where appropriate, audit actions to ensure actions are closed out as required
• Assist in training sessions to ensure Engineering teams have an understanding of quality requirements and procedures.
• Assist any member of the Compliance team as required.
• Support the Operations team in delivering the required compliance needs in GxP regulated areas and with the day to day site management when requested.
• Set, own and manage CAPA actions.
• Initiate engineering change controls, action, monitor and track to closure.
• Lead and participate in Engineering or quality related Deviations.
• Assist with writing and review of contract specific procedures as required.
• Represent the quality compliance function at EMCOR / Client meetings and presentations.
• Provide quality support including staff training on required topics.
• Promote continuous systems improvements and good practice.
• Proactively encourage the strict adherence to the client procedures.
• Implements and monitors controls to prevent deviations or non-conformities.
• Complies with all client and EMCOR policies and procedures and adheres to company standards.
• Sign GxP Documents as required by procedure and based on appropriate training.
• Performs other duties as requested.
• Uses client systems such as EAM, IMMS, Beamex CMX, to extract and perform data management reviews in support of trend analysis, CAPA or deviation