Production Equipment Qualification Specialist
The Production Equipment Qualification Specialist will oversee the site commissioning and qualification organization in support of capital projects, leading activities focused on commissioning and qualifying OSD process equipment, Computerized System.
The individual will ensure on-time and within-budget completion of C&Q work activities of low to major complexity, responsible for driving the commissioning and qualification activities of the tableting area (incl. equipment CSV..) according to company standards and regulatory requirements.
The specialist will effectively manage assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies. Interface with multiple sites and departments to accomplish predefined goals and provide technical guidance including production OSD equipment, automation, and Computerized System validation.
The candidate will design and author the validation/qualification approach, provide scientific rationale and acceptance criteria, generate and review/approve commissioning, validation/qualification protocols/reports.
Key Responsibilities:
* Oversight of site commissioning and qualification organization in support of capital projects
* Leading activities focused on commissioning and qualifying OSD process equipment, Computerized System
* Ensuring on-time and within-budget completion of C&Q work activities of low to major complexity
* Driving commissioning and qualification activities of the tableting area according to company standards and regulatory requirements
* Managing assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies
Requirements:
* Degree in Engineering or Science related discipline
* 5 years of relevant pharmaceutical industry experience (with a focus on OSD pharmaceutical application validation in a GMP environment)
* Experience in managing complex projects
* Project and change management experience
* Experience with Product Life Cycle Management
* Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.) with direct interactions including face-to-face interaction and response to audit questions
Benefits:
We offer long-term opportunities, fluent English and French language skills are required. Full-time employment as an Associate level consultant is available.
This position involves IT Services and IT Consulting industries and offers a chance to unlock community knowledge in a new way.