The Production Technical Support Manager Third-party is responsible to provide technical support for products manufactured or packaged at third party companies. His main tasks are to lead the team, plan the work, make decisions, manage resources and performance to achieve organizational goals. From an expertise standpoint, he is responsible to solve technical problems (formulation, manufacturing, packaging, analysis, etc) and quality (complaints, investigations, CAPA, etc) to ensure a continuous products supply or to minimize the interruption. Provide technical support to third-party companies, if required, for raw material change, manufacturing or packaging site change. Finally, he works in collaboration with Quality, PMO and Supply chain on priorities projects for the organization.
Responsibilities :
Related to products manufactured / packaged by third parties :
- Responsible to lead the team, plan the work, assign priorities, make decisions, manage resources and performance to achieve organizational goals.
- Responsible for budget management and planning.
- Responsible for employee evaluation and training.
- Responsible for problem-solving activities and process improvements, as well as changing manufacturing or packaging sites for manufactured / marketed products. Responsible for recommending / implementing corrective actions / solutions in collaboration with third parties.
- Responsible for providing technical support / expertise for resolving deviations, investigations, and CAPA for the manufacturing and packaging of commercial products. Develop strategies in collaboration with third parties, review and approve deviations, investigations, and reports as needed.
- Responsible for providing technical support / expertise for changes in raw material sources for commercialized products.
- Evaluate potential impacts on the finished product resulting from changes in API and / or excipient sources, or changes in the manufacturing processes of these raw materials.
- Provide support to third parties as well as various internal groups responsible for third parties (e.g., PMO, Planning, Procurement, Validation, QA, and Regulatory Affairs).
- Participate in other assigned tasks.
Skills, Knowledge and Abilities :
Excellent interpersonal & communication (written and oral) skills.Good ability to influence and have recommendations accepted.Demonstrated leadership and organizational skills.Ability to anticipate problems and propose solutions.Ability to work under pressure and set priorities.A positive approach to change and proven aptitude for initiative and innovation.Strong analytical skills, demonstrated ability to manage multiple / complex projects across functions.Knowledge of dosage forms (solids, semi-solids, liquid dosages, injectables and inhalers) and manufacturing and packaging processes.Ability to communicate in French and English. The person will be required to work with regulatory authorities, suppliers and / or clients located outside Quebec and will be required to read and write documentation in English only.