Gcp Project Coordinator

4 semanas atrás

Lisboa, Portugal Adamas Consulting Tempo inteiro

Company Description

**Job Description**:
To provide high quality, professional quality assurance and quality management services to the pharmaceutical industry. Duties will be carried out in accordance with the ADAMAS Quality Management System (QMS) including business and personal objectives as agreed during the annual performance appraisal process.

**General Responsibilities**
- Deliver projects on behalf of client companies within the pharmaceutical industry
- Actively participate in the ADAMAS learning and development process
- Perform other reasonable duties as requested by the job holder’s Line Manager

**Responsibilities**

Projects may relate to any ADAMAS service offered to clients. This may include audits, preparation of training material and delivery of training, development of client QMS/SOPs and/or general consultancy.

Specific duties may include:

- Performing the role of Project Lead and client liaison
- Oversight of key functional department outputs, to ensure all project-related activities are delivered according to project milestones
- Acting as ongoing liaison between internal and external stakeholders to manage audit scheduling throughout the project lifecycle, from business development through to operational delivery
- Promote and maintain a high level of audit schedule awareness across the organisation
- Maintain accurate spreadsheets and other tracking tools to reflect project status
- Preparation of project training materials and training delivery
- Providing support to the Consultant team throughout the audit process, for example:

- Project Plan preparation
- Audit report QC
- CAPA tracking and follow-up to audit closure
- Project document administration
- Assist with induction training and on-boarding activities for newly hired members of the Consultant team
- Providing support to the Business Development function, including project scope development, proposal generation, capabilities and bid defence

**Learning and Development**

The job holder must maintain an up to date knowledge of international regulatory requirements and industry guidelines / best practices governing the pharmaceutical industry. Advantage should be taken of learning and development opportunities to facilitate increasing competence and achieving the job holder’s full potential. This will include:

- Participation in the process whereby knowledge and learning are shared across the organisation (i.e. by attending training meetings and presenting when requested)
- Maintaining competence records to provide evidence that individuals have the necessary education, training, experience and skills to perform their assigned tasks
- Attendance at external training courses
- Participation in ‘on-the job’ training, this may be either as a trainee or trainer
- Reading publications and other sources of literature, e.g. regulatory authority websites, CQA Advisor, QUASAR

**Other Duties**

The job holder may be requested to assist with other aspects of ADAMAS’s activities, including:

- Projects defined in SMART objectives
- Non critical QC of project deliverables
- Assistance with the ADAMAS QMS e.g. QMS document preparation and review, process improvement initiatives, internal and client audits
- Completion of timesheets and expense claims in a timely and accurate manner to ensure correct billing to clients
- Any other duties as reasonably assigned

Additional Information

Our people and the way we work set us apart. We work closely with our clients, providing industry-leading innovation and knowledge to deliver solutions that add genuine value to their business.

We place great worth on development and collaboration so we can best succeed together. When needed we also place great importance on intellectual curiosity and the ability to work autonomously.

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