Quality Assurance & Regulatory Affairs Sr Analyst
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Job Location:
Buenos Aires - Argentina
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cold Room/Freezers -22degreesF/-6degrees C Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.) WarehouseJob Description
As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
Join our Quality Assurance & Regulatory Affairs team at Thermo Fisher Scientific where youll contribute to ensuring product quality and regulatory compliance. As a QA Supervisor youll lead and develop a team of quality professionals while overseeing quality operations including batch record review quality monitoring and continuous improvement initiatives. Youll collaborate with cross-functional teams to enhance quality excellence and maintain our high standards for product safety and compliance. This position offers the opportunity to contribute by helping ensure the quality of products that enable our customers to make the world healthier cleaner and safer.
REQUIREMENTS:
- Pharmacist with 1-2 years of experience in quality assurance and regulatory affaris in a regulated manufacturing or distribution environment (mandatory being pharmacist)
- Experience within pharma healthcare or biotech industries
- Fluent in english
- Good knowledge and /or experience with cGMP regulations local regulations and quality systems
- Experience with quality management software systems (e.g. TrackWise SAP)
- Experience with deviation management and CAPA systems
- Experience with documentation systems and electronic quality management tools
- Experience hosting regulatory inspections and customer audits
- Understanding of validation and qualification principles and requirements
- Ability to support quality culture and continuous improvements
- Excellent project management and organizational skills
- Ability to build relationships and collaborate across all organizational levels
- Ability to effectively manage multiple responsibilities in a deadline-oriented environment
Required Experience:
Senior IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
