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10% or so editing change controls, 10% to 15% writing change controls, 50% + of the job working with multiple stakeholders.
Cross functional teams to ensure all parts of the document are approved on multiple projects .(this is the project management experience the manager is looking for)
Responsible for the development, creation, and revision of controlled documentation.
Accordance with Client policies and procedures, current GMP, 21CFR820, ISO 13485 and AATB Standards.
Establishes partnerships and works with Change Control, Quality Engineer team members, and other cross functional managers/supervisors and development engineers/teams to ensure that controlled documents being revised contain the correct information per process/product specifications.
Requirements:
Must have previous experience with change control.
Previous experience in pharmaceutical, medical device, or biotech industries.
Software:
Veeva One Vault (Quality Docs) OR Track wise.
Strong Communication both written and verbal THIS IS VERY IMPORTANT.