Summary
- Provides assistance in managing the day to day activities related to audits and inspections
- Coordinates and supports audit and inspection logistics at the site (scheduling of activities, planning, issuing agendas, reports etc..)
- Participates actively during inspections and audits, including performing readiness exercises before and during inspections / audits
- Assists in the development, implementation, and maintenance of procedures for the site Compliance programs
- Prepares training materials on GMP Topics, including inspection readiness and audit management
- Assist in development of effective auditing tools and training aids
- Trains SMEs and support staff on specific roles, responsibilities, processes, and systems associated with inspection management and support
- Initiates and coordinates writing and on-time completion of regulatory commitments, responses, and other correspondence
- Collaborates with internal teams on key issues ensuring compliance with cGMPs and other regulations
- Identifies compliance risks and escalate issues to appropriate levels of management for resolution
Qualifications :
Bachelors degree or higher in life sciences, chemistry, engineering, or related field
5 years of experience
Must have knowledge and experience with cGMP manufacturing, quality, and compliance as well as US and global cGMP requirements
Experience with regulatory inspections and internal GMP audits
Excellent verbal and written communication skills with ability to prepare written communications and communicate problems to management with clarity and accuracy.
Demonstrates a high degree of attention to detail, with strong documentation expertise. Able to effectively multi-task and demonstrate strong organizational skills.
Possesses the ability to generate and present audit / quality metrics via PowerPoint / Excel.
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