The specialist assists the Technology Transfer Supervisor in providing technical support for technology transfer activities. He / she works with a team of specialists (production, quality assurance, quality control, validation, engineering, etc.) to support production batches and / or external customers' batches regarding our operations. These activities include assistance in writing and reviewing manufacturing and packaging records.
2. PRIMARY FUNCTIONS
- Support the Supervisor during technology transfer activities, including manufacturing and packaging of batches from internal or external customers;
- Assist in the drafting of production and packaging records;
- Participate in the optimization and / or adaptation of manufacturing processes during technology transfers, including the manufacturing of pilot-lab or production-scale trials;
- Support the Supervisor in the production of feasibility and characterization batches when introducing new products into production, in partnership with the various groups involved;
- Support production and assess impact when determining / changing pilot and commercial batch sizes;
- Participation / support for the writing of :
- Annual reviews;
- Change controls;
- Carry out and document investigations in partnership with the groups involved;
- Contribute to problem-solving during technology transfer activities; Provide monthly reports (KPIs);
- Perform any other related tasks deemed relevant to the position.
3. EXPERIENCE REQUIREMENT AND APTITUDES
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