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Are you looking for a stimulating work environment with technical challenges that meet your highest expectations and opportunities for advancement?
Reporting to the Manager, Tech Transfer & Process, the candidate will manage diverse projects related to commercial scale-up activities, development and process transfer on production. As a part of a multidisciplinary team your expertise will be sought throughout the project as required.
Your main responsibilities would be:
- Develop procedures, commercially scale-up formulations developed by the Formulation Department;
- Ensure the transfer of procedures developed by Confab clients;
- Ensure transfer of information to the Validation Department;
- Provide day-to-day technical support to all departments involved.
- Write and revised associated documents (MBRs, PBRs, protocols, reports, OOS, deviations, etc.) and ensure compliance with filing documents and/or regulatory requirements;
- Manage procedures, change controls, event reports and investigations.
- Bachelor’s degree in engineering, pharmacy, chemistry or other relevant area;
- Minimum of five (5) years of experience in similar functions in Pharmaceutical Industry;
- Relevant achievements in liquid, solid, and semi-solid product transfer projects (ANDA, NDA, ANADA, DIN);
- Good knowledge of regulatory requirements relating to development, human scaled and site transfers;
- Excellent ability to work in multidisciplinary teams and manage multiple projects in parallel;
- Bilingual oral and written.
We would be delighted to get to know you and to discuss your professional interests and career objectives.
Confab Laboratories is part of Mylan Pharmaceuticals ULC, one of the largest pharmaceutical companies in the world with over 35,000 employees across 165 countries.
Confab specializes in the development and manufacturing of non-sterile pharmaceutical drugs (CDMO). The plant, located on the south shore of Montreal, is growing with major expansion investments underway to support an increasing volume of R&D projects as well as pioneering new dosage forms.
The company complies with both Canadian and US regulatory requirements. To know more about Confab Laboratories please visit the website at http://www.confab.com/
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