Job Description

Duties / Responsibilities:

Working within a small Quality and Compliance team on an EMCOR client’s pharmaceutical site, you will ensure these aspects of the engineering service provided meet the client’s procedural requirements.

Support the compliance team in implementation of business requirements around GxP needs.

Provide support for issues related to third party contractors, equipment, systems or utilities having significant risk to the client operations.

Conduct appropriate compliance internal audits on a regular and ad hoc basis.

Support Client & 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.

Provide advice, guidance and mentorship to any member of the Compliance team as required

Attend compliance or operations meetings when invited and/or deputise for Line Manager.

Assist Line Manager in reviewing staff quality training requirements to ensure that training identified met the requirements of the contract.

Sign GxP Documents as delegated by the Line Manager

Ensure monthly reports/KPIs commitments are published and submitted to the Line Manager.

Maintain a quality culture between the Company, GSK R&D and Third-Party Contractors through good communication and documentation.

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.

Person specification

Degree similar in Engineering or manufacturing within pharmaceutical/healthcare industry, or equivalent related work experience within a regulated manufacturing or processing environment

Willing to travel within the South East of England to support multi-site operations and audits.

Full UK driving license.

Benefits

25 days + bank holidays

Company Pension Scheme

Flexible benefits available

Required Knowledge, Skills, and Abilities

Must have demonstrated experience in a safe, team-based, high-performance, quality-driven environment.Experience and knowledge of GxP guidelines and regulations would be advantageous 7+ years working in a regulated Engineering Quality, facilities maintenance, or a manufacturing operations organization Specialized training or certification in quality assurance audits preferred. Ability to identify and act on Compliance Risks within responsible area. Experience in review of audit related documentation. Expertise with Microsoft Word, Excel and RCA Tools. Experience of EAM asset management system, Trackwise, IMMS, Electronic Document management System, is advantageous. Excellent interpersonal and communication skills to effectively work with management and employees at all levels within an organization, including key stakeholders, customers and facing the regulatory auditor.