Job Information
ThermoFisher Scientific Manager, QA in Ahmedabad, India
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degrees, Office, Will work with hazardous/toxic materials
Job Description
Manager, QA
Thermo Fisher Scientific Inc. is looking for a motivated and experienced professional to join our team in Ahmedabad as Manager, QA. In this role, you will be responsible for ensuring that clinical supplies are stored and distributed in compliance with Fisher Clinical Services approved procedures and policies, as well as industry regulations such as cGMP, cGDP. This position offers a chance to contribute to high-quality systems and work closely with both internal and external partners on quality-related issues.
Job Responsibilities:
Ensure compliance with internal standards, local, and international quality and regulatory guidelines for clinical trials supply chain activities
Support delivery of monthly reporting on key performance indicators and provide insights on trends, risks, and mitigation plans
Provide guidance and advice on regulatory and quality matters to clients, suppliers, and internal associates
Handle internal and external audits and follow-up on resulting observations and opportunities for improvement
Perform quality activities required by the Quality Management System
Partner and collaborate to find opportunities and solutions related to regulatory and quality matters impacting the business
Support management reviews of process performance, product quality, and the Pharmaceutical Quality System, advocating for continual improvement
Ensure that a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management
Job Requirements:
Bachelor’s degree or equivalent experience in life science/medical/pharmacy/quality assurance/regulatory affairs or related field
4+ years of strong QA and production experience or experience in GMP/QMS settings in quality assurance and regulatory affairs
Knowledge of IMP process, including handling complex protocols and key clients
Ability to handle complex problems/projects with independent decision-making and analytical thinking skills
Flexible, adaptable, and strong customer management skills
Ability to work independently under pressure and handle multiple tasks
Good organizational, written, and verbal communication skills in English
Thermo Fisher Scientific Inc. is an equal opportunity employer (EOE) and values diversity in our workforce. We are committed to providing equal opportunities to all individuals regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We also provide reasonable accommodations to individuals with disabilities in the job application process. If you need assistance or an accommodation due to a disability, please contact us at 1-855-471-2255.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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