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- Tasks: Ensure engineering services meet compliance and quality standards on a pharmaceutical site.
- Company: EMCOR UK revolutionises facilities management with a focus on innovation and people.
- Benefits: Enjoy 25 days holiday, health cash plan, gym discounts, and paid volunteering days.
- Why this job: Join a team dedicated to creating better workplaces while minimising environmental impact.
- Qualifications: Degree in Engineering or related experience in regulated environments required.
- Other info: Diversity is celebrated; all backgrounds are encouraged to apply.
The predicted salary is between 40000 - 60000 £ per year.
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.
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/Responsibilities:
- 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.
- Implement and monitor controls to prevent deviations or non-conformities.
- Comply with all client and EMCOR policies and procedures and adhere to company standards.
- Sign GxP Documents as required by procedure and based on appropriate training.
- Perform other duties as requested.
- Use 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.
Quality & Compliance Specialist (Engineering) employer: EMCOR UK
Contact Detail:
EMCOR UK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality & Compliance Specialist (Engineering)
✨Tip Number 1
Familiarise yourself with GxP guidelines and regulations, as this role heavily involves compliance in a regulated environment. Understanding these standards will not only help you during interviews but also demonstrate your commitment to quality and compliance.
✨Tip Number 2
Network with professionals in the pharmaceutical and engineering sectors. Attend industry events or join relevant online forums to connect with people who can provide insights about EMCOR UK and the specific challenges they face in quality and compliance.
✨Tip Number 3
Prepare to discuss your experience with compliance audits and CAPA actions in detail. Be ready to share specific examples of how you've successfully managed compliance risks in previous roles, as this will showcase your expertise and problem-solving skills.
✨Tip Number 4
Research EMCOR UK's unique insight platform, 'One Data World'. Understanding how they leverage data-driven intelligence can give you an edge in interviews, allowing you to discuss how you can contribute to optimising their services and enhancing workplace experiences.
We think you need these skills to ace Quality & Compliance Specialist (Engineering)
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Quality & Compliance Specialist position. Understand the key responsibilities and required qualifications, so you can tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in quality assurance and compliance, particularly within regulated environments like pharmaceuticals. Use specific examples that demonstrate your understanding of GxP guidelines and your ability to manage compliance risks.
Craft a Strong Cover Letter: Your cover letter should not only express your interest in the role but also showcase your knowledge about EMCOR UK and its commitment to quality and compliance. Mention how your values align with their mission to create a better world at work.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a role focused on quality and compliance.
How to prepare for a job interview at EMCOR UK
✨Understand GxP Guidelines
Make sure you have a solid grasp of Good Practice (GxP) guidelines, as this role heavily involves compliance with these regulations. Be prepared to discuss how your previous experience aligns with these standards and how you can contribute to maintaining them.
✨Showcase Your Audit Experience
Since the position requires conducting internal audits, highlight any relevant audit experience you have. Discuss specific instances where you identified compliance risks and how you addressed them, demonstrating your proactive approach to quality assurance.
✨Prepare for Technical Questions
Expect technical questions related to engineering and compliance processes. Brush up on your knowledge of equipment, systems, and utilities that are critical to client operations, and be ready to explain how you would handle potential issues.
✨Emphasise Team Collaboration
This role involves working closely with various teams, so be sure to emphasise your interpersonal skills and ability to collaborate effectively. Share examples of how you've successfully worked in team settings to achieve compliance goals or improve processes.