Receive regular GMP training, regulatory training, and company role training/assessments; attend data reliability training on schedule to strengthen awareness of data reliability.
Comply with company and role-related requirements; participate in establishing GMP-compliant physicochemical laboratory area management procedures and workflows and ensure normal operation of the laboratory area.
Participate in drafting quality standards and SOPs for analytical methods related to physicochemical testing of materials (raw/packaging).
Participate in drafting quality standards and SOPs for analytical methods related to process control, intermediates, and finished products in physicochemical testing.
Participate in drafting protocols for validation and stability studies related to the Physicochemical Group and issue related reports.
Be responsible for process water (steam) monitoring, including adjustments to the monitoring...