cmc quality solutions specialist.

Here are the mission as a CMC Quality Solutions Specialist :

• Product Change Control Committee preparation and change controls follow-up
• Maintenance and lifecycle management of QA product flows
• Audits and Inspection anticipation and readiness
• Product metrics
• Review of Annual Stability Plan
• SOPs and other control documents writing, review and approval as needed
• Building and maintenance of Product QA knowledge (i.e., Product(s) SharePoint(s))
• Risk management and mitigation if applicable (e.g., follow-up on risk actions with QA stakeholders)
• Review and approval of CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned products as
• Preparation and execution of Product launches from QA perspective (support in QA-RA assessment, support in QA activities, complaint readiness, shipping validation) as needed

Here are the rerquirements as a CMC Quality Solutions Specialist :

• At least 3 years of experience in the pharmaceutical/biological industry in a quality management role. Operational experience in GMP in the field of quality, manufacturing or quality control would be an asset.
• Fluent and confident use of the English language in speaking, reading and writing.
• Must be able to work independently for assigned activities with limited supervision.
• Must have the skills and experience to work in multicultural environments.
• Must be able to independently analyze data and information to draw conclusions and make effective decisions.
• Must have the ability and agility to adapt to different types of products, tasks and quality managers in a collaborative mindset.
• Must be able to identify and suggest opportunities for harmonization and synergies to improve working methods on global products.
• Project management skills would be an asset.
• Experience in data integrity assessment would be an asset.
• Understanding of CMC regulatory requirements would be an asset.