CyberscopeTV

About the job

EMCOR UK are offering a 12 month Fixed Term Contract for a Compliance Specialist to join our team at GSK Ware. Job Purpose: Working within a small Quality and Compliance team on an EMCOR client's pharmaceutical & Consumer Health R&D sites, you will ensure these aspects of the engineering service provided meet the client's procedural requirements. Responsibilities: Support the compliance team in implementation of business requirements around Consumer Health R&D 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 Consumer Health R&D 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 Consumer Health R&D 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 Consumer Health R&D 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 Consumer Health R&D 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. Assist operations with the organisation of their actions, including but not limited to Change Controls, OORs, Concerns & Risks, and Assurity actions. Person Specification Degree / HNC / similar in Engineering or manufacturing within pharmaceutical/Consumer 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. Willing to travel within the South East of England to support multi-site operations and audits. Full UK driving license. Benefits • 25 days annual leave • Pension schemes • Cycle scheme • Company sick pay • Flexible Working policy where applicable and feasible • Employee benefit discounts including childcare vouchers • Personal Development opportunities: our appraisal process is designed to identify your training needs and the personal development goals needed to progress your career. • Staff canteen (subsidised) at Stevenage, Ware and Weybridge (Not sure about the other sites). • Discount on GSK Products in Onsite shop (Aqua fresh, Sensodyne, Voltarol,... ) • In Learning with (url removed) content (Linked in Learning), Career Innovation, Leading Edge - online platforms for professional development and growth • Creating Balance; our steering group promotes Diversity and Inclusion throughout our business. • Mental Health and Wellbeing; Mind is our EMCOR UK charity, and as such mental health and wellbeing is an important topic for us. To support this we have an Employee assistance programme available to you with free advice on dealing with personal problems such as; debt, legal issues, relationships, addictions and stress. • Charitable Giving and Community; we offer two days off per annum for you to support your chosen charity. • Recognising Excellence; our annual Employee Excellence Awards are designed to recognise and reward individuals or teams for their outstanding contribution and performance at work

Company

Company Name

Address

Hertfordshire,United Kingdom