Project Coordinator

Eramol is a dynamic pharmaceutical company specialising in the manufacture, importation, warehousing & distribution of commercial and clinical trial medicines across the UK and rest of the world. Eramol has invested significantly to expand their UK & Irish manufacturing capabilities to include large-scale tablet & capsule manufacture, tablet coating and blistering of tablets & capsules.

**MAIN DUTIES AND RESPONSIBILITIES**

This job description outlines the current main responsibilities of the post. However, the duties of the post may change and develop over time and may therefore be amended in consultation with the post holder,

**1. **Quality & Improvement**
- Applies principles of Good Manufacturing Practice in all areas of projects operations
- Actively participate in internal process improvement program and initiatives
- Leading on process mapping of Project Processes and refining systems & processes to maximise efficiency of the Projects Team
- Compile all Project metrics and operational metrics across all Projects and present to senior management at weekly/monthly meetings

**2. **Communication & Liaison (Internal & External)**
- Collaborate with internal project management, QA and Production team
- Work and liaise with the Production Team to provide support on the development of existing or new production, QC processes
- Work and liaise with the Production Team to provide input into production scheduling process
- Work and liaise with the Production Team to provide support on logistics / distribution of products
- Work and liaise with external suppliers to identify all materials (including raw material, packaging material and consumables) required for the manufacture of project specific products
- Work and liaise with QA team to ensure project specific components, raw materials and bulk products are released and meeting project specific deadline
- Work and liaise with QA team to facilitate closure of Quality Exception Reports & Change Controls where appropriate
- Work and liaise with Qualified Person to ensure finished products are certified and released according to project specific deadline
- To draft and develop relevant operational GMP/GDP documentation including but not limited to the following:

- product specifications
- QC & stability specifications
- raw material specifications
- product specification file
- logistics documentation
- Coordinate and communicate of all relevant activities both internal and external to ensure that all services and products are delivered within specific timeline.
- To provide back up support to other members of the Project Team
- To facilitate and participate customer teleconferences, visits and audits as required.
- To work with customers for troubleshooting, investigating complaints and determining solutions to customer’s requirements.
- Escalation of customer complaints to Projects Manager and/or QA as applicable

**3. **Documentation & Reporting**
- To maintain study filing systems and maintain accurate records for all work undertaken
- Timely provision of reports and other project information for internal and external stakeholders
- Monitor product activities and day to day business
- Collect and collate all relevant information relevant for project set up, including but not limited to the following:

- Details of study design
- Study protocol
- Label text (facilitate translation if applicable)
- Randomisation lists
- Pack size and presentation
- Quantity and number of campaigns required
- Distribution documentation requirements

**4. **Leadership & Management**
- To attend all relevant meetings as agreed or organised by the Senior Management or departmental leads
- To be responsible for the recruitment and selection of Project Support Associates staff and to ensure that company policies on recruitment are adhered to. In addition, the post holder may be asked to contribute to the recruitment of staff in other areas of the organisation.
- To ensure that Company and departmental induction processes are completed for all new staff and that the company Probationary Policy is applied.
- To manage all Project Support Associates and ensure that all staff working within the area are suitably trained, regular reviews occur and all training documents are contemporarily maintained.
- To ensure that all Project Support Associates receive their quarterly performance review & annual appraisal.
- To ensure that effective communication channels are set up and maintained within the Projects Team so that all grades of staff are kept up to date with the information that is appropriate for their role.
- To chair weekly meetings of Project staff and ensure that all relevant information is cascaded to other staff members.
- To contribute to the strategic planning process for developing new services &/or processes
- To ensure that all Project Support Associates have the appropriate training and that to consider the future need of the training and competency assessment of staf