Stays updated with regulatory and quality standards, evolutions in GXP compliance and best practices, including Standard Operating Procedures adherence.
Maintains Quality KPIs and other key metrics stablished.
Analyses of raw materials and excipients, while meeting compendial and in-house specifications.
Analyses of primary packaging material for compliance with regulatory and technical and in-house specifications.
Performs lab-based analyses of utilities (such as water for injection, deionized water, steam, compressed air and nitrogen, including new lines/extension validations).
Manages the laboratory, including organization and cleanliness, equipment maintenance and operation, consumables stock management.
Supports and communicate with other departments on required activities needed to improve the workflow.
Supports management in laboratorial activities related to Lab investigations to proper define the root cause.

Quality Control Analyst

Key skills