Senior Analytical Scientist
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| Job Type | Permanent |
| Area | Cork |
| Sector | Laboratory/Scientific |
| Start Date | |
| Advertiser | Mary King |
| Job Ref | 2605 |
| Job Views | 293 |
- Description
-
Team Horizon is seeking a Senior Analytical Scientist for to be part of the team on our client’s pharmaceutical site in Cork. The Senior Analytical Scientist will work within the Site Technology team to provide analytical support to scale-up, product support and clinical supply projects. This role will support all analytical aspects of a product life cycle from development through to commercial manufacturing.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Support all aspects of a product life cycle, including development, registration, clinical and commercial manufacture, leading analytical programmes for the introduction of new products into the commercial facility
Support the processes for the manufacture of existing and new products, in particular the analytical and laboratory-based procedures and analytical trouble shooting
Support the performance of validation activities deemed within the scope of Site Technology, including cleaning, laboratory equipment and process validation
Support the Site Technology department in meeting departmental and site KPI’s along with all aspects of new technology introduction, plant performance, process improvements, cGMP compliance and troubleshooting during the commercial life span of the product.
Manage, lead, perform and execute the analytical aspects of the Site Technology function and provide direction and leadership with respect future analytical activities of the team
Record all test details, raw data and results accurately, neatly and in a timely manner, in line with the Site Technology laboratory procedures with cGMP and cGLP principles
Write and/or review procedures, protocols, study plans and reports and participate in the scheduled maintenance and calibration of analytical equipment along with all housekeeping
Conduct all laboratory tasks in a responsible way and take line management responsibility for analysts in the site technology team
Execute stock control and analysis of raw materials, in-process material, and finished product in compliance with project schedules, SOP’s and standard methods.
Manage and execute calibrations and PM of equipment as required to ensure correct functionality while co-ordinating maintenance schedules with external suppliers to ensure compliance with schedule and in-house procedures.
Participate in training and development activities to ensure that new technologies are applied and that the required competency level is developed.
Execute validation studies and transfer studies to ensure equipment, methods and personnel are appropriately qualified.
Liaise/co-ordinate/support the validation activities associated with the introduction of new equipment, or technologies while being responsible for training analysts (QC & STE) and other personnel in the new technologies
Performing accurate reviews and approval of documents and data to ensure accuracy and compliance while also analysing trends and ensuring that the principles of data integrity are adhered to at all time
What you need to apply:
A relevant 3rd level technical /scientific qualification to Ph.D level is highly desirable
At least 3 years experience in a similar regulated environment.
Ability to manage both projects and day to day activities ensuring that priorities are effectively
Be able to take the necessary guidance and instruction on both cGMP and technical projects
Demonstrate a commitment to identifying and improving the management processes.
Good time management and people skills.
Must have strong technical-competence.
High level of organisational and administration skills (MS Word, MS Excel, MS Outlook.
Strong knowledge of cGMP activities.
Must be self-motivated and capable of working autonomously.
