Moreton, Merseyside DATS Recruitment Ltd

We are seeking a dedicated individual to join our team for a 12-month contract based on the Wirral in a pharmaceutical research facility. The primary responsibility of this role is to oversee the coordination of the DIRA's (Data Integration Risk Assessment s). The compensation for this position is competitive, with rates in the market, estimated at between £200-£250 per day (umbrella rate - Inside IR35). However higher rates will be considered if justified by experience.

Overview:

We are seeking a dynamic and experienced individual to join our team as a Senior Administrator or QMS Technician ideally with some Project Management type experience. The Administrator will ensure the successful completion of DIRAs.

The ideal candidate will have some background in project management and an understanding of Quality Management Systems (QMS).

Key Responsibilities:

• Coordinate and oversee the execution of Data Integrity Risk Assessments (DIRAs) in accordance with established protocols and timelines.
• Serve as the subject matter expert in Quality Management Systems (QMS) and provide guidance on best practices and methodologies.
• Assist and support in conducting Failure Mode and Effects Analysis (FMEA) throughout the DIRA process.
• Assign and manage dedicated resources, such as QMS Technicians or Project Managers, to focus on scheduling, completing templates, and conducting site investigations.
• Ensure that all DIRAs are completed thoroughly and accurately, adhering to regulatory requirements and organisational standards.
• Collaborate with cross-functional teams to address any identified risks or discrepancies and develop appropriate action plans.
• Monitor and track progress on DIRAs, identifying any potential delays or roadblocks and implementing corrective measures as necessary.

The Senior Administrator will need to deal with documents such as:

1. 1. Flow Chart basic understanding is needed
   2. FMEA failure mode effect analysis, basic understanding is desirable
   3. Systems Review basic understanding of IT-related systems is needed
   4. Process Checklist basic project management skills are needed
   5. GAP Summary ability to create reports showing where gaps are and to communicate effectively.

Qualifications

• Good level of education
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Strong organisational skills and attention to detail, with the ability to manage multiple priorities and deadlines.
• Ability to adapt to changing priorities and work effectively in a fast-paced environment.
• Proficiency in relevant software applications (e.g., Microsoft Office, project management tools).