Our client is looking for an eQMS Project Superuser to join their team on a hybrid basis for 12 months.
Role Purpose:
The focus of this role is to provide wide-ranging support to the implementation of the eQMS system (Veeva) across the business. In this role, you will perform a variety of tasks in support of the development, validation and implementation of the new eQMS, ensuring that the needs of all areas and all regulatory requirements are met. This project role also includes the migration of existing documentation from across CPI's documentation systems and subsequent testing, in addition to assisting in the development of communication and training packages to support the project.
Key Responsibilities:
- Embrace and role model the desired behaviours to exemplify the company values, promoting an ethical, positive company culture.
- To maintain consistent and documented compliance with all relevant Safety, Health and Environment (SHE), Quality, Good Manufacturing Practice (GMP), Data Integrity (DI), and best practice requirements.
- To work as part of a project team to deliver the successful implementation of the eQMS system.
- Vault QMS:
- As part of the workshop groups, utilising the process maps, development of workflows across all quality management systems.
- Communication of progress with wider Project stakeholders and escalation of issues.
- Support the remediation of issues and wide acceptance of solutions.
- Performance of User Acceptance Testing.
- Support the development of the validation templates.
- Performance of Validation testing, including completion of validation documentation.
- Support the development, review and approval of documentation including policies and SOPs.
- Support the development and roll-out of the training package.
- Support the transition of users from SHEQ-IR to Vault QMS.
- Support the decommissioning of SHEQ-IR for Quality Incidents in accordance with the project plan.
Essential Qualifications:
Educated to A-Level level (or equivalent) with good maths, IT and literacy skills, plus relevant industrial experience.
(Desirable Qualifications:
Educated to HNC or Foundation Degree level (or equivalent) in a Scientific/Engineering discipline plus relevant industrial experience. Or Educated to Degree level (or equivalent) in a Scientific/Engineering discipline plus relevant industrial experience.)
Essential Knowledge and Experience:
Will possess quality system expertise across a broad range of quality management systems with understanding of the purpose of each quality process/system.
Demonstratable experience of operating within a regulated environment, developing, implementing, and monitoring quality systems.
Will exhibit professional mastery of principles and practices in varied quality systems, gained in industrial environments.
Strong attention to detail with a thorough approach and good organisational skills.
Ability to work in fast paced environment, flexibility to adjust with moving priorities and ensuring attention to detail remains first class.
Can demonstrate evidence of knowledge sharing and network building practice across teams or groups.
Has ability to apply theoretical and practical quality tools and techniques to contribute to business activities.
Can provide examples of actively utilising cross-team collaboration to achieve desired results.
Has confidence to use own judgement and initiative within standard quality practices, as well as an understanding of when to seek advice from colleagues.
This vacancy is being advertised on behalf of Gem Partnership Ltd who are operating as an employment agency.
To stay safe in your job search we recommend that you visit JobsAware, a non-profit, joint industry and law enforcement organisation working to combat job scams. Visit the JobsAware website to get free, expert advice for a safer job search.