BSA Validation hybris
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Job Location:
Monthly Salary:
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.
Summarized Purpose:
This role is part of a small global team focused on validating the lab instrumentation in accordance with the European Medicines Agency (EMA) guidelines. This role will work on system development lifecycle deliverables work on project timelines participate in client and regulatory inspections and work closely with various departments and vendors to ensure effective communication accuracy and support throughout the project lifecycle.
Essential Functions:
- Requirement gathering for instrumentation
- Validation test case creation and management
- System documentation management
- Knowledge of system regulations is a bonus
Qualifications:
Bachelors degree or equivalent and relevant formal academic/vocational qualification.
Previous experience that provides the knowledge skills and abilities to perform the job or equivalent combination of education training and experience.
Experience with requirement gathering and validation of computerized systems
Good MS Office skills.
Ability to estimate level of effort for small to medium-sized projects.
Strong problem-solving and analytical skills.
Strong planning and organizational skills.
Solid understanding of clinical trials operational processes and terminology and solid understanding of the software development life cycle (SDLC).
Ability to attain maintain and apply a working knowledge of applicable SOPs/WPDs and process maps.
Working Conditions and Environment:
Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
For Labs-based staff travel up to 60-80% of time domestically with extended overnight stays. Light/occasional travel for corporate-based staff.
For Labs-based staff exposure to biological fluids with potential exposure to infectious organisms.
For Labs-based staff personal protective equipment is required such as protective eyewear garments and gloves.
Exposure to fluctuating and/or extreme temperatures on rare occasions.
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
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
