JOB DESCRIPTION - Almac



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|JOB DESCRIPTION |

|DATE: |July 2019 |

|POSITION: |Project Coordinator |

|BUSINESS UNIT: |Almac Clinical Services |

|LOCATION: |Craigavon |

|REPORTING TO: |Project Group Manager |

|RESPONSIBLE FOR (PEOPLE): |NA |

OVERALL ROLE OBJECTIVE:

The principle function of the Project Services department is the day-to-day management of all Almac Clinical Services customers. The department coordinates all aspects of the delivery of a customer’s project as specified in the quotation. In order to achieve this, the department is divided into a customer support group which includes supply chain management and an operations support group. The operations support group is further divided into two key areas: production and distribution.

The Project Coordinator working in production is responsible for performing all tasks associated with the successful management of the manufacture and packaging of clinical trial supplies.

The Project Coordinator working in distribution is responsible for performing all tasks associated with the successful management of the distribution and return of clinical trial supplies.

The Project Coordinator working in supply chain management is responsible for performing all tasks associated with the successful delivery of supply chain services to the client.

Project Coordinators provide a supportive role to Project Managers and/or supply chain coordinators/supply chain managers

JOB SPECIFIC RESPONSIBILITIES:

Production

1 Schedule operations with production planning to meet customer timelines

2 Assist in the generation and maintenance of project plans for awarded projects to communicate production timelines and responsibilities for tasks to the Project Leader and customer

3 Draft detailed written instructions for the manufacture/packaging of each batch of material ensuring full compliance with current Good Manufacturing Practice

4 Prepare documentation to support drug product and component receipt for production activities

5 Track ordering and receipt of drug product and components for production activities, assisting Logistics and QC in the clearance upon receipt at Almac

6 Expedite materials and documents through internal Almac systems

7 Escalate project specific production issues to the project Team or the Project Group Manager as appropriate

8 Initiate the label proof process and liaise with label generation as necessary

9 Generate Medication Number List Import Forms if applicable

10 Calculate quantities of drug product and input components needed per production operation

11 Allocate drug product and components to production jobs

12 Track the progress of the production operations against the project plan and advise the Project Team of any issues affecting the planned production dates

13 Schedule and gather documents for QP release of Almac produced finished goods

14 Schedule analytical services to meet customer timelines

15 Monitor inventory levels and expiry dates of components to ensure adequate levels of inventory are available for production operations

16 Initiate the order for ancillary supplies and components for production operations as required ensuring that the appropriate approvals are obtained

17 Assist in progressing rework of returned material per customer request

18 Generate change requests for material receipt and production related documentation

19 Assist in the generation of quality incident reports and technical queries relating to project specific production issues

Distribution

1 Draft detailed distribution instructions and depot project instructions

2 Draft instructions for return, accountability and destruction at Almac facilities and Almac contracted depots

3 Set up distribution protocols in conjunction with Software Development/Quality Assurance to enable a timely and accurate drug delivery process

4 Generate Medication Number List Import Forms for distribution only studies

5 Schedule and gather documentation for QP release of customer supplied finished goods, scheduling analytical testing if required

6 Ensure required lots of finished goods are released for shipment to the appropriate countries in advance of the first shipment date

7 Generate the Autoship Setup Form

8 Complete protocol setup in the inventory release file (IRF) generator

9 Generate Inventory Release Files

10 Set trigger levels, monitor inventory levels and expiry dates of shipping components (e.g. shippers, temp tales), ancillary supplies (e.g. syringes, dosing instructions/leaflets, alcohol swabs) and ancillary drug supplies (e.g. rescue medications) to ensure adequate levels of inventory are available for subsequent shipments from Almac warehouses and depots

11 Notify the customer when inventory levels are low for customer supplied components and supplies

12 Initiate the order for ancillary supplies and components supplied by Almac ensuring that appropriate approvals are obtained

13 Monitor expiry dates of finished goods and notify the Project Leader as required

14 Arrange for shipment of samples to the customer or third party

15 Generate memos providing instructions to the sites and depots on re-labelling activities and upon approval from the Project Leader, assemble and distribute the notifications and materials for re-labelling to sites, depots and clinical monitors, tracking and reconciling the completion of the re-labelling activities

16 Review and track the receipt of Drug Accountability Logs communicating with sites and/or clinical monitors as required ensuring that the logs are completed.

17 Track destruction of returns and forward Certificates of Destruction to the customer

18 Generate change requests for distribution and returns related documentation

19 Assist in the generation of quality incident reports and technical queries relating to project specific distribution issues

Supply Chain Management

1. Temperature excursion assessment and resolution based on an agreed process between Almac and the customer

2. Shipment tracking and temperature excursion compliance monitoring

3. STEMS site compliance monitoring and communication of updates to customer

4. Site inventory review within prescribed parameters as well as inventory status tracking at both Almac facilities and contracted depots.

5. Coordination of label generation and approval (regulatory and translation) services in line with customer specific process requirements for label provision

6. Supply chain health checks on integrated studies as defined by Supply Chain Manager

Customer Service (All areas)

1 Ensure all customer contact is carried out with a high level of professionalism in order to develop and maintain good working relationships with each customer

2 Receive and follow through on all customer queries ensuring a response is supplied in a timely manner

3 Attend teleconferences and meetings with customer as required

4 Take minutes and generate agendas and action items for customer meetings and teleconferences

5 Generate routine customer specific reports

6 Deal with customer complaints according to defined procedures and escalate to the Project Leader/Supply Chain Manager as appropriate

7 Maintain a professional approach at all times while representing Almac

8 Fulfil any necessary administration duties required to assist the team

9 Log all billable time against the correct project in the Timesheet system

10 Provide support to the Project Team as deemed necessary by the Project Group Manager

Other (Operational)

1 Provide support and act as the backup to the Project Manager when requested for routine customer communication and project team updates

2 Perform all tasks within the necessary timeframe defined for each project

3 Provide regular updates to the Project Leader for global projects when required

4 Maintain folders in Livelink to a high standard to ensure full project file information is available

5 Complete departmental Key Performance Indicators (KPIs) for specific projects as required

This role may require coverage beyond normal working hours on a regular basis. It is a condition of your employment that you are able to fulfil this requirement of the role.

GENERAL ROLE RESPONSIBILITIES:

|Quality |Ensure GMP is adhered to in all areas of work. |

|Health & Safety |Understand Company’s Health & Safety Policy and follow all company |

| |HSE procedures. Report all accidents or any unsafe conditions in |

| |the work place. |

|Training and Development |Ensure training has been received before undertaking specific duties|

| |and that all training is recorded in training records. |

|Human Resource Management |Adhere to all HR policies and procedures, to include all absence |

| |policies and procedures. |

|Communication |Communicate within your own department to ensure that all relevant |

| |information is forwarded to the appropriate personnel on a regular |

| |and timely basis. Provide regular updates to your line manager |

| |regarding progress on required duties and the status of any |

| |projects. |

|Equal Opportunities |Observe and adhere to the company's Equal Opportunities and Dignity |

| |at Work policies ensuring that a neutral and harmonious work |

| |environment is maintained in which bullying and/or harassment does |

| |not occur. |

|Core Competency Framework |Ensure that all job specific responsibilities relating to the |

| |overall role objective are carried out in accordance with the |

| |requirements outlined within the Almac core competency framework. |

|By signing this Job Description I accept that I have received and read the Job Description and have accepted the responsibilities |

|identified therein. |

|EMPLOYEE’S SIGNATURE: | |

|PRINT NAME: | |

|DATE: | |

|This job description should not be regarded as conclusive or definitive. It is a guideline within which the individual jobholder works.|

|It is not intended to be rigid or inflexible and may alter as the Company’s strategic direction changes. |

|PERSON SPECIFICATION |

|DATE: |July 2019 |

|POSITION: |Project Coordinator |

|BUSINESS UNIT: |Almac Clinical Services |

|LOCATION: |Craigavon |

|REPORTING TO: |Project Group Manager |

|RESPONSIBLE FOR (PEOPLE): |NA |

| | | | |

| |ESSENTIAL |DESIRABLE |ASSESSMENT METHOD |

| |REQUIREMENT |REQUIREMENT | |

| | | | |

|QUALIFICATIONS |Bachelor’s Degree (or equivalent) |Bachelors Degree (or equivalent) qualification within a |Application Form and |

| |qualification |Life Science, Engineering or Business Management related|Documentary Evidence |

| | |discipline | |

| |or | | |

| | | | |

| |Equivalent previous experience working in | | |

| |at least 1 of the following: | | |

| | | | |

| |Manufacturing related environment | | |

| |Logistics related environment | | |

| |Project Management role | | |

| |Customer Service role | | |

| | | | |

|EXPERIENCE |N/A |Previous experience within a Business to Business |Application Form and |

| | |customer service role |Interview |

| | | | |

| | |Previous experience within a Production / Manufacturing | |

| | |/ Laboratory / Quality Control or Quality Assurance | |

| | |environment | |

| | | | |

|KEY SKILLS |Proficiency in the use of Microsoft Office |Proven working knowledge of GMP, GCP and Quality Systems|Psychometric testing/ |

| |packages (to include Outlook, Word, Excel | |Interview |

| |and PowerPoint) |Proven ability to compile detailed instructional | |

| | |documentation | |

| |Effective communication skills (verbal, | | |

| |written, presentational and interpersonal) | | |

| | | | |

| |Ability to work effectively on own | | |

| |initiative and effectively contribute | | |

| |within a team environment | | |

| | | | |

| |Proven ability to adopt a methodical | | |

| |approach, managing multiple tasks | | |

| |simultaneously whilst maintaining a high | | |

| |level of accuracy in all work carried out | | |

| | | | |

| |Effective problem solving and decision | | |

| |making ability | | |

| | | | |

| |Analytical, logical approach | | |

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|ALMAC CORE COMPETENCIES |

| | | |

|COMPETENCY |BEHAVIOUR |ASSESSMENT METHOD |

| | | |

|RESULTS DELIVERY |Delivers results on time, within constraints and in line with company |Interview |

| |policy and procedure and organisational strategy. Demonstrates a | |

| |continuous drive for quality and a commitment to excellence. | |

| | | |

|PROACTIVE SOLUTIONS |Analyses and uses experience and logical methods to make sound decisions|Interview |

| |which solve difficult problems. Seeks practical/workable and innovative | |

| |methods to deliver solutions. | |

| | | |

|LEADS BY EXAMPLE |Promotes a clear vision and mission. Acts as a positive role model for |Interview |

| |the organisation, fostering a climate of teamwork and development. | |

| | | |

|COMMUNICATION |Communicates clearly and effectively. Promotes the exchange of ideas and|Interview |

| |information across the organisation. Fosters dialogue to ensure everyone| |

| |understands what is going on. | |

| | | |

|CUSTOMER FOCUS |Strives to exceed the expectations and requirements of internal and |Interview |

| |external customer; acts with customers in mind and values the importance| |

| |of providing high-quality customer service. | |

| | | |

|JOB SPECIFIC KNOWLEDGE |Demonstrates required job knowledge and understanding to successfully |Interview |

| |and competently fulfill or exceed the requirements of their post. | |

| |Follows correct procedures and guidelines (SOPs). | |

| |Proactively demonstrates a desire to enhance and develop their job | |

| |knowledge. | |

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