
QA Senior Compliance Specialist, Night Time Operations
Are you a highly skilled and experienced Quality Assurance professional with a passion for ensuring compliance in the pharmaceutical industry? Do you thrive in a fast-paced and dynamic work environment? If so, we have an exciting opportunity for you at Sanofi as a QA Senior Compliance Specialist for our Night Time Operations team. In this role, you will be responsible for ensuring the highest level of quality and compliance in our manufacturing processes during the night shift. We are seeking a detail-oriented and proactive individual with a strong background in quality control and regulatory compliance. If you have a proven track record of success in this field and are looking for a new challenge, we encourage you to apply for this position. Join our team and make a positive impact on the lives of patients worldwide.
- Develop and maintain a thorough understanding of all relevant regulations, guidelines, and standards for pharmaceutical manufacturing.
- Monitor and evaluate compliance with quality standards and regulations during night time operations.
- Identify and communicate potential compliance issues to management and provide recommendations for resolution.
- Conduct quality audits and reviews of manufacturing processes and documentation to ensure compliance.
- Collaborate with cross-functional teams to implement corrective and preventive actions for any identified compliance issues.
- Train and educate employees on quality and compliance standards to promote a culture of continuous improvement.
- Participate in the development and maintenance of quality systems and procedures to ensure compliance with regulatory requirements.
- Assist in the preparation and submission of regulatory filings and responses to inspection findings.
- Keep up-to-date with industry trends and changes in regulations to ensure compliance of the night time operations.
- Act as a subject matter expert on compliance-related matters and provide guidance to team members.
- Represent the company during regulatory inspections and audits, ensuring all necessary documentation is readily available.
- Continuously assess and improve quality and compliance processes to promote efficiency and effectiveness within the night time operations team.
- Communicate regularly with management on compliance status, issues, and potential risks.
Bachelor's Degree In A Science Or Healthcare Related Field, Such As Chemistry, Pharmacy, Or Biology.
Minimum Of 5 Years Experience In A Quality Assurance Role Within The Pharmaceutical Industry.
In-Depth Knowledge Of Fda Regulations, Including Cgmp, Glp, And Gcp.
Experience With Conducting Audits And Inspections Of Manufacturing Facilities And Ensuring Compliance With Regulatory Requirements.
Strong Communication And Leadership Skills, With The Ability To Effectively Train And Mentor Junior Team Members.
Quality Assurance
Process Improvement
Data Analysis
Auditing
Quality Control
Team Leadership
Compliance Management
Risk assessment
Time
SOP Development
Regulatory Knowledge
Gmp Standards
Communication
Conflict Resolution
Customer Service
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a QA Senior Compliance Specialist, Night Time Operations in Framingham, MA, USA is $80,000 - $105,000 per year. However, this can vary depending on factors such as experience, qualifications, and company size. Some companies may offer higher salaries and additional benefits for this position.
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Sanofi SA is a French multinational pharmaceutical company headquartered in Paris, France, the world's fifth-largest by prescription sales. Building a More Equitable Future through Inclusive Clinical Trials · Rethinking the science of COPD · Grassroots Manufacturing Solutions for a Healthier Planet.

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