Our client is a multi-national pharmaceutical organisation who have multiple sites in Ireland. This role is based in their diverse Corporate office based in North Dublin. Previous experience is Oral Solid Dose Process Development is essential for this exciting and diverse role.
- You will lead and coordinate process improvement strategies for existing formulations and provide technical support as required to the Manufacturing Department.
- Responsible for coordinating projects such as Scale-ups, Second sourcing, New Equipment Introduction, Launches, etc. and deputise for the Process Development Managers required
- Maintain the validated state of all production processes to ensure compliance with current European and Customer requirements.
- Assist in all Product Transfer activities include transfers from R&D, affiliates and third party manufacturing sites., and assist in process improvement strategies for existing formulations
- Provide technical support as required within the manufacturing / QC Departments, and maintain and coordinate the validation schedule.
- Preparation of process validation protocols and reports in accordance with cGMP and customer requirements. , and assist in the timely execution of Trial and validation batches. To ensure deadlines are met and all correct sampling is carried out and all necessary records are logged.
- Assist in troubleshooting of existing formulations and suggest suitable improvements and to assess and support any regulatory changes required, and assist in the transfer and scale up of products from both R&D and other manufacturing sites.
- Maintain and follow all relevant SOPs, and support the implementation of the Operational Excellence Program on the site by identifying, leading and implementing improvements.
- Provide technical support as required by management, and ensure that appropriate standards of GMP are maintained in all aspects of work
- Adhere to all company and legislative health, safety and environmental requirements, and participate in the quality management systems including investigations, deviations and change control, and to assist in any other duty required for the maintenance of the stability program
- Science degree and proven experience in a similar role.
- 3+ years in a scientific Process Development role
- Experience in an Oral Solid Dose environment is essential
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747