Technology Transfer support required for Home Market Projects, for existing and new products. The role includes the following:
· Provide Process Descriptions and Facility Fit Comparisons.
· Assess manufacturing requirements prior to the transfer of processes into new manufacturing facilities.
· Assist in the writing and review of manufacturing / batch records, and SOPs if necessary.
· Provide manufacturing descriptions and technical evaluations for master files.
· Gather, trend, and analyse process generated data
· Generate process evaluation reports and process transfer documentation from Master File Data.
· Provide technical support to improve understanding of responsibility of contract manufacturer.
· Ensure all tasks are performed within cGMP guidelines.
· Support Technical Agreement implementation
· Build process knowledge repository/database.
· Arrange support when necessary during manufacturing operations.
Required Education / Experience / Knowledge / Skills
• BS Life Sciences or Engineering with 2+ years of experience.
• Ability to communicate clearly the timelines and important milestones.
• Ability to adapt to a quickly changing environment.
• Knowledge of cGMP and other applicable regulations.
• Ability to effectively communicate issues and ideas with peers and with management.
• Ability to facilitate meetings with cross functional teams.
• Excellent interpersonal, written, and oral communication skills.
• Ability to build effective working relationships throughout the organization.
Please apply in writing enclosing a cover letter and an up to date C.V
Ballymacarbry, Clonmel, Co. Tipperary
(Fax Number: 052 – 6136311) or e.mail: firstname.lastname@example.org