Quality & Compliance Specialist

Duties/Responsibilities

Location: Stevenage- OFFICE BASED

Salary: £50,000 Per annum depending on experience

Working Hours: Monday to Friday 8am-5pm- OFFICE BASED

Benefits: 25 days holidays + Bank holidays, Health Cash Plan, Discount Shopping, Gym, Days Out, Learning & Development opportunities, Paid Volunteering Days, plus many more. (Amend as necessary)

About EMCOR UK

At EMCOR UK, we revolutionise facilities management by combining our engineering heritage and innovation capability. We prioritise people in everything we do, collaborating closely with our customers to understand all their needs, from the big picture to day-to-day operations. Our purpose is to “create a better world at work”. Using our unique insight platform, "One Data World," we harness data-driven intelligence to make informed decisions, adapting our services to meet our customers’ evolving requirements. This allows us to cultivate an enhanced workplace experience for their teams whilst optimising efficiency, meticulously managing every asset, and minimising their impact on the planet. All supported by our commitment to safety, compliance, and assurance. Our partnering approach empowers our customers to shape a better future. Whether guiding their path to net zero or redeveloping their facilities for enhanced efficiency, we create better places for work whilst taking away the burden of facility operations, freeing up our customers to concentrate on their business.

Job Purpose

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.

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.
  
  

Person Specification

• Degree / HNC / similar in Engineering or manufacturing within pharmaceutical/healthcare industry, or equivalent related work experience within a regulated manufacturing or processing environment
• Experience and knowledge of GxP guidelines and regulations advantageous
• 5+ 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, CDMS, is advantageous.
• Excellent interpersonal and communication skills to effectively work with management and employees at all levels within an organization, including customers and facing the regulatory auditor
• Must have demonstrated experience in a safe, team-based, high-performance, quality-driven environment.
  
  

At EMCOR UK, we embrace and celebrate diversity in all its forms.

We welcome applicants from all backgrounds and experiences, regardless of age, race, gender, sexual orientation, religion, disability, or any other characteristic that makes you unique. We believe that a diverse and inclusive workforce fosters creativity, innovation, and better problem-solving.

We encourage applications from all candidates and are committed to providing equal opportunities for employment and growth, supported by our inclusive policies and practices.

Join us in our endeavour to build a culture of mutual respect and equity, a place where every voice is heard, and every individual is championed.

Join us in building a better world at work.

Benefits

• Industry leading maternity & paternity policies
• Refer a friend scheme – worth £500 per referral
• GEMS – Internal recognition scheme with vouchers for Amazon and retail/dining
• Extensive learning & development opportunities, including opportunities for progression
• Discount shopping, gym, mobile, family activities, insurance, dining experiences, car leasing and breakdown cover
• Bike To Work Scheme
• Health cash plan - Benefits covered include optical, physiotherapy and a health & wellbeing
• Dental scheme
• Access to health assessments
• Employee Assistance Programme - Offering guidance and advice on Personal, Health, Legal and Financial queries