Responsibility to work with BioPharmaceutical CMC Solutions (CMC) and management to ensure all associated equipment management activities are managed within established deadlines and to the required regulatory standards.
Close liaison with EM Management, Lead Scientists, Project Managers and Laboratory Operations, across all GMP sites, to ensure that all information relating to equipment management and deliverables are managed consistently and efficiently.
- Exhibits mastery relating to familiarity and review of equipment documentation, including but not limited to Standard Operating Procedures, Equipment Training Documentation, Metrology Specification Requests, Equipment Validation Documents, Total Management System Forms.
- Manages quality records relating to equipment systems to an appropriate standard (e.g. quality events, change management, CAPA, audit comments).
- Assists with the identification, gathering and reporting of KPI's for the Equipment Management group locally and shares insights on this with the global manager
- Supports regulatory / client audits and visits as required.
- Serves as the subject matter expert and main point of contact for EM processes within the group.
- Coordinate large project scopes (e.g. new equipment onboarding) to ensure proper execution and timely completion. Including global liaison where appropriate.
- Prioritise daily responsibilities of EM Associates according to business needs.
- Ensures that procedures of the team are carried out in a timely and cost effective manner.
- Solves problems independently, contacting internal or external clients for clarification as needed.
- Leads process improvement and harmonisation projects relating to EM processes.
- Ensures discrepancies which are escalated by the team are resolved.
- Provides client feedback to the Equipment Management team.
- Incorporates peer review tasks and responsibilities into workload.
- Acts as a team representative within the Department on appropriate teams and / or committees.
- Supports quality investigations, CAPA and change control assessments as required.
- Independently resolves issues through contacting internal or external customers as appropriate.
- The post holder should ideally have a relevant degree and/or 3 to 5 years relevant industry experience.
- The ability to get things done by influencing others (both internal and external).
- Up to date knowledge of regulatory guidelines.
- Knowledge of capabilities and expertise of the Covance organisation and companies that may provide support services.
- Commercial and client awareness, interpersonal and negotiating skills.
- Learn and maintain knowledge of process excellence, tools and activities.
- Minimum of 5 years industry experience in a relevant field.
- Experience of line management is highly desirable as the role will involve direct supervision on a daily basis.
- Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project).
- An understanding of health and safety policies, Company policies and procedures, and an understanding of GMP/GLP/GCP.
- The post holder should be able to communicate effectively at all levels, across different sites, with other Covance employees, as well as external clients, suppliers, etc.
Posting ID: 584171132Posted: 2020-11-03