Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
TS
Hybrid Compliance Specialist, Audits and Inspections, Client Audits
Posted 3 months ago
About the role
- Compliance Specialist executing quality and compliance processes at Thermo Fisher Scientific. Facilitating quality activities and mentoring staff while ensuring compliance with regulations.
Responsibilities
- Execute quality and compliance processes across the organization
- Facilitate the tracking and reporting of quality and compliance activities
- Maintain tools and materials and provide expertise to advance the vision of the department
- Investigate and resolve issues, monitor metrics, and maintain reports and documentation associated with quality and compliance activities
- Manage quality and compliance activities, ensuring they are carried out thoroughly and brought to a successful finish
- Coordinate smaller projects and process/quality improvement initiatives with proven results
- Communicate with representatives from other departments to ensure quality and timelines are maintained regarding compliance activities (e.g., client audits, CAPA, and procedural documents)
- Mentor staff and serve as a team lead for group projects or process improvement initiatives
Requirements
- Bachelor's degree in a related field or equivalent formal academic/vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
- Experience with clinical project coordination, clinical project administrator or similar experience is required
- Able to go onsite to the Austin, Texas office is required (1-3 times per month)
- Client facing experience is preferred
- Excellent oral and written communication skills
- Strong organizational and time-management skills
- Solid organizational and time-management skills
- Firm knowledge of the clinical trial process
- Thorough knowledge and understanding of ICH GCP and other relevant regulations and guidelines
- Effective problem solving skills
- Strong attention to detail
- Ability to work independently as required
- Strong computer skills; ability to learn and become proficient with appropriate software
- Ability to multitask and prioritize competing demands/work load
- Demonstrated flexibility and adaptability
Benefits
- Relocation assistance is NOT provided
- Must be legally authorized to work in the United States without sponsorship
- Must be able to pass a comprehensive background check, which includes a drug screening
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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