Sr Manager, Validation and DI
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Job Location:
Saint Louis, MI - USA
Monthly Salary:
Not Disclosed
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
First Shift (Days)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
What Makes This Opportunity Unique
At Thermo Fisher Scientific Inc. our objective is to invent world-class solutions that empower our customers to enhance the health cleanliness and safety of the world. As the Sr Manager Validation and DI you will play a pivotal role in ensuring the accuracy and reliability of our data systems. Join our dedicated team of professionals in the United States and help us achieve outstanding outcomes!
Job Responsibilities
Validation Strategy Development
- Develop and implement comprehensive validation strategies for data systems and processes.
- Develop validation protocols and procedures to guarantee data accuracy and reliability.
Data Integrity Management
- Coordinate data integrity processes to guarantee data accuracy consistency and reliability.
- Implement data integrity controls and monitor adherence to these controls.
- Perform routine audits and evaluations of data integrity procedures.
Quality Assurance
- Guarantee that all data validation and integrity procedures are in line with the companys quality criteria.
- Collaborate with the Quality Assurance team to integrate data integrity into the overall quality management system.
- Engage in quality audits and inspections offering knowledge on data validation and integrity.
Compliance and Regulatory Adherence
- Ensure compliance with relevant regulatory requirements and industry standards (e.g. FDA EMA GxP).
- Stay informed about updates in regulations and standards impacting data integrity and validation.
Process Improvement
- Identify areas for improvement in data management and validation processes.
- Implement guidelines and continuous improvement initiatives to improve data integrity.
Training and Education
- Formulate and present training programs focusing on data integrity and validation practices.
- Instruct employees about the significance of data accuracy and their contribution to upholding it.
Collaboration and Communication
- Collaborate closely with IT Quality Assurance Regulatory Affairs and other departments to guarantee data integrity.
- Communicate effectively with collaborators to address data integrity issues and implement solutions.
Documentation and Reporting
- Maintain detailed documentation of validation and data integrity processes.
- Compile and deliver reports regarding data integrity status and validation activities to senior management.
Qualifications
Education
- Bachelors degree in Life Sciences or a related field. Masters degree is desirable.
Experience
- Minimum of 5 years managing a team.
- At least 7 years of experience in data validation data integrity or a related domain is required.
Required Experience:
Manager
Key Skills
- Account Management
- Apache Web Server
- Jpa
- ABAP
- Community Support
- Islamic Banking
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
