We are seeking a highly skilled and experienced Senior QA Specialist to join our dynamic team.
• In this role, you will be responsible for overseeing the quality assurance process, ensuring that our products meet both Local and Global quality standards.
Top 3 skills:
1. Batch Record Review experience.
2. GMP experience.
Responsibilities:
• Execute all activities following quality and regulatory standards and procedures.
• Promote a quality mindset and quality excellence approach to all activities.
• Provide on the floor support to Manufacturing activities.
• Perform review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
• Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, and Self inspection auditing, QA reporting and approval of GMP documentation.
• Review and approve Standard Operating Procedures, logbooks and QC data
• Continue support of continuous improvement culture and industrial excellence methodologies.
• Support employees and respective departments in a manner which is clear in approach, communication, and action.
• Provide proactive communication to customers to ensure timely escalation and resolution of issues. Follow up on issues to ensure completion in a timely manner. Support cross functional communication in all manners.
• Support batch release of drug substance including compilation of documentation, as necessary.
• Support SAP integration and master data migration, as applicable.
• Support GMP compliance and inspection readiness within organization. Assist in coordination of work for the QA Operations team to facilitate timely release of product lots.