Supports and implements quality and compliance processes. Facilitates the tracking and reporting of activities and tasks. Maintains tools and materials, and offers expertise to advance the vision of the department. The Quality Difference at Thermo Fisher Scientific: What makes their quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with their customers always in mind. Their team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of their products and services that are improving lives around the world. When you join their team of quality professionals, you’ll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with them.
Name of the
Organization: Thermo Fisher Scientific
Requisition
ID: R-01274906
Positions: Associate
Compliance Specialist, Quality Event Management
Location: Remote (WFH)
- India
Salary: As per
company Norms
Educational
Qualifications:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years)
Skills
Required:
- Effective oral and written communication skills to support communication in English
- Strong prioritization and time-management skills
- Knowledge of the clinical trial process
- Knowledge and understanding of ICH GCP and other relevant regulations and guidelines
- Shown problem solving skills, including root cause analysis, corrective/preventive action(s) and effectiveness checks
- Strong attention to detail
- Strong computer skills; ability to learn and become proficient with appropriate software
- Demonstrated ability to prioritize tasks for efficient workload management
- Shown flexibility and adaptability
- Effective judgment, decision making, issue and risk management skills
- Strong creative and critical thinking skills
Roles &
Responsibilities:
- Researches and addresses issues using problem solving methodology, documents in accordance with ALCOA principals and metric compliance related to quality activities.
- Knowledgeable of quality processes and ensures appropriate execution and completion.
- Participate in small to medium-scale process improvement initiatives.
- Communicates with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents).
- Develops support materials, presentations, and/or tools to support department's remit and strategies.
- Job Complexity: Works on problems of diverse scope with subject matter input, appropriate management of data, requires good problem solving skills
- Job Knowledge: Experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
- Supervision Received: Normally receives detailed instructions on all work.
- Business Relationships: Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior collaborators in own area of expertise.
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