Job Title: Production Equipment Qualification Specialist
* Oversee qualification activities for the revamping of the tableting manufacturing area, including Design Qualification (DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Equipment Qualification, Handover, and Project Close-Out.
About the Role
This position involves overseeing qualification activities for the revamping of the tableting manufacturing area, including Design Qualification (DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Equipment Qualification, Handover, and Project Close-Out.
Key Responsibilities
* Provide oversight of site commissioning and qualification activities supporting capital projects.
* Lead activities focused on commissioning and qualifying OSD process equipment and Computerized System validation.
* Manage C&Q work activities to ensure timely and within-budget completion.
* Drive qualification activities according to company standards and regulatory requirements.
* Collaborate with multiple departments and sites to provide technical guidance.
* Design and author validation/qualification plans, protocols, and reports.
* Lead complex investigations, change controls, and corrective actions related to C&Q activities.
* Implement structures, tools, and processes to manage C&Q activities.
* Participate in internal and external audits as a Subject Matter Expert (SME).
Your Profile
* Degree in Engineering or Science (e.g., life sciences, Mechanical, Chemical).
* Minimum 5 years of relevant pharmaceutical industry experience, especially in OSD pharmaceutical validation within a GMP environment.
* Experience managing complex projects for at least 5 years.
* Strong problem-solving, communication, and interpersonal skills.
* Ability to work independently and across organizational boundaries.
* Fluent in English and French.
* Experience with Product Lifecycle Management and health authority inspections.