Pharmaceutical Process Transfer Specialist
3 weeks ago
Reporting to the Manager, Technology Transfer OSD, the Pharmaceutical Process Transfer Specialist supports the technology transfer team in the transfer of new pharmaceutical processes/products, mainly, but not limited to oral solid dosage (OSD) forms, developed internally by the Formulation team or externally by a business partner.
Key Responsibilities:
Support the technology transfer team in the transfer of new pharmaceutical processes/products from the development phase to the commercial phase
- Creates analysis and sampling plans.
- Coordinates sampling.
- Performs blend uniformity sampling.
- Assists with batch manufacturing and issues daily reports, as needed.
- Sends the samples for analysis.
- Performs physical characterization tests on the blend samples (e.g. particle size distribution, bulk and tapped density, flowability).
- Extracts and compiles in-process and analytical data.
- Supports, if necessary, the issuance of certificates of analysis and other analysis reports.
- Collaborates in writing reports, as needed.
- Supports the archiving of department documentation.
- Provides support, as needed, to answer questions/requests from several groups (e.g. Formulation, Validation, Quality Assurance, Production).
- Provides training to new technicians, as needed.
Required Skills and Knowledge:
- Bilingual English/French (oral and written). As part of his/her tasks, the person will be required to read and write documentation in English only.
- Good GMP knowledge.
- Good teamwork ability.
- Organizational skills in managing multiple projects.
- Good writing skills.
- Conscientious.
- Analytical mind.
- Dynamic.
- Self-governed.
- Good knowledge of Windows environment and MS Office tools (Outlook, Word, Excel, Powerpoint, Teams).
- Knowledge of LIMS laboratory software is an asset.
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