Demonstrate Subject Matter Expert for deep knowledge on equipment qualification, relevant compendia chapters, data integrity initiatives, change controls, GMP processes, 21 CFR part 11, GAMP 5 etc.
December 11, 2022
Manage quality improvementprojects, including planning, communicating, developing action plans, and providingregular project updates.
November 20, 2022
Participate in compliance walkthroughs and help drive the closure of any observations.
November 29, 2022
Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
December 28, 2022
Develops, implements, and maintains standard operating procedures, programs, and processes to ensure conformance with quality, regulatory, and company requirements.
January 16, 2023
Supports the field management team by coordinating with various departments leads to reinforce regulatory guidelines and standards to ensure continuous compliance.
February 18, 2023
Assists in the research and organization of licensing and accreditation data pertaining to each state of operation in order to standardize policies and procedures and ensure compliance with regulatory and accreditation guidelines.
February 19, 2023
