EMCOR UK are currently recruiting for a Quality Compliance Specialist to be based at our client site in Ware. This is a fixed term contract.
Working hours: 8:00 - 17:00
Working within a small Compliance team on an EMCOR client's pharmaceutical site, you will ensure the delivery of compliant engineering services which support the manufacturing utilities.
Reviews EMCOR and subcontractor/ vendor operations which support the engineering facilities to the life science areas, and documentation for compliance with local and global regulatory standards. Must have a good understanding of Quality Systems and Compliance within a regulated engineering or manufacturing environment. Serves as a Quality Assurance (QA) resource to support engineering quality documentation and other compliance related activities. Helps to coordinate implementation of best practices tasks across departments, sites and regions as directed.
Serves as backup for Compliance team as required and provide compliance guidance and/or assistance to other team members in support of deviations, CAPA, Risks and change controls supporting the engineering areas. Support the Compliance team in implementation of business requirements around GxP needs, make decisions when needed and provide guidance. Provide compliance support for issues related to engineering equipment, utilities, instruments, processes and systems having significant risk to the client account. Assist in training sessions to ensure Engineering and Operational teams have the required understanding of quality and procedural requirements.
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.
Degree 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 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
Willing to travel within the South East of England to support multi-site operations and audits.
Full UK driving license.
Must have demonstrated experience in a safe, team-based, high-performance, quality-driven environment.
25 days + bank holidays
Company Pension Scheme
Flexible benefits available