- Develop and implement processes, procedures, and instruction to sustain and improve the Quality Management System
- Support Top Management in the development and implementation of quality systems strategies and objectives
- Oversee and coordinate the communication and release of corporate documents for all sites
- Develop and support site document control procedures and work instructions
- Develop and execute process improvements to ensure Site Quality processes meet users’ needs and requirements
- Coordinate project work related to integration of sites and migration to integrated systems.
- Assist and lead audits and assessments, both internal and external, to demonstrate compliance with GMP, ISO, CMDR, and EUMDR regulations
- Support Quality investigations as needed
- Manage and facilitate external standard assessments
This is not an exhaustive list of duties or functions and might not necessarily comprise all the essential functions.
Skills:
- Excellent working knowledge of current USA Food and Drug Administration (FDA) and global laws, regulations, and standards, particularly EUMDR
- Familiarity with statistical data analysis tools and concepts
- Ability to objectively deal with individuals using appropriate tact and diplomacy to establish and maintain a congenial relationship
- Proficiency in technical writing
- Outstanding organizational skills
- Basic experience or knowledge on issue resolution disciplines (e.g. problem solving/decision making, root cause analysis, etc.)
- Must be able to manage stressful situations and to handle controversial issues
- Must be familiar with all aspects and elements of a quality system including but not limited to corrective and preventive action (CAPA), management responsibility, product realization and measurement, analysis and improvement processes
- Highly compliance-oriented to firmly adhere to the principles of the regulations and standards
- High attention to detail
- Demonstrated proficiency with MS Office suite, Adobe Acrobat, PowerBI and various data sources
Education:
- Bachelor's Degree and 4 years of relevant experience, or Associate's Degree and 6 years of relevant experience, or High School Diploma or Equivalent and 8 years of relevant experience
- Bachelor’s Degree in life sciences field with minimum 5 years of relevant work experience preferred
📌 Quality Systems Specialist (India)
🏢 Fusion Life Sciences Technologies
📍 India
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