QA Project Support
Description de la fonction
- Defining projects objectives and road map
- Guiding and supervising the activities and schedule of the projects to ensure each aspect is complete and accurate
- Developing projects plans and presenting scope, solutions to manager
- Coordinating, motivating, and leading a matrix team for the successful delivery of assigned projects involving cross-functional colleagues, and other stakeholders.
- Managing and escalating projects risks and issues
- Process mapping
- Support Electronic Batch record roll out across sites with implementation of exception-based review.
- Prepare the Selection and proll out exception-based release digital solution
- Preparation of business case for one button digital release solution
Profil
- Quality generalist, with a minimum of 5 years working in the pharmaceutical/biologics industry in a process improvement position or releasing/batch record review function.
- Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
- Must have a process improvement mindset, able to influence different stakeholders, find common ground and bring stakeholders closer together with aligned approach.
- Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments.
- Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally, especially at senior management levels.
- Be able to coach/train/mentor colleagues and deliver training within area of expertise
- Holding a Qualified Person registration number is an asset.
- Fluent in English & French
- Experience with electronic batch record review is required
Offre
- Voiture d'entreprise