Sterility Assurance Vaccine Project Manager Vacancy @ Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health.
Job Title: Project Manager- Sterility Assurance- Vaccine
Req Id: R2630236
Qualifications:
- Minimum B.S./B.A. degree is required, preferably in one of the following disciplines: Chemistry, Biochemistry, Microbiology or Pharmacy
- Minimum 2-3 years working within Microbiology/Contamination Control in a GMP facility is required, ideally in the pharmaceutical/biotechnology industry.
- Experience in microbiological and sterility testing, environmental monitoring, cleanroom management, quality control endotoxin testing, and contamination control strategy.
- Solid experience with oversight of aseptic processing and the associated international aseptic processing regulations
- An understanding of routine QC operations, including testing and documentation practices.
- Audit/Inspection Experience
- Method validation experience
OTHER SKILLS/COMPETENCIES REQUIRED for SUCCESS:
- Excellent written and oral communication to include accurate and legible documentation skills
- The ability to work in a fast-paced environment; team-oriented; independent work skills and a strong work ethic.
- The ability to interface and communicate directly with clients may be required.
- Strong collaboration and communication skills are required.
- The ability to multitask and an adequate sense of urgency are a must.
- Knowledge of continuous improvement techniques and problem-solving skills
- Proven leadership, verbal and written communication, organizational, critical thinking, and action-oriented.
Preferred:
- Professional writing capability.
- Experience with laboratory electronic systems
- Proficient using Microsoft Office
- Proven logic and decision-making abilities and critical thinking skills.
Major Responsibilities:
- Assure Pearl River and Meriden site’s environmental control and microbiology contamination control programs comply with applicable regulatory standards
- Develop and lead EM/microbiology/contamination control programs
- Lead and maintain aseptic training program and sterility assurance/contamination control risk assessments
- Support with Disinfectant Efficacy Studies, Environmental Monitoring Trend Reports,
- Perform EU Annex-1 gap analysis and close them.
- Function as Subject Matter Expert with contamination control related deviations etc.
- Develop programs and educate personnel on the importance of microbiological and contamination control
- Promote a quality mindset and quality excellence approach to all activities
- Identify, track and facilitate resolution of Microbiological technical issues
- Track, trend, and analyze EM and microbiology testing data for the site
- Recommend action and continuous improvement plans
- Summarize findings and recommendations for management and team awareness and present at routine Quality Council meetings
- Author and/or review and approve SOPs, protocols, reports, and test method documents as applicable
- Compliance with cGMP and Standard Operating Procedures at all times
- Documentation review and approval
- Provide technical guidance and expertise to QC Microbiology Team and external departments
- Effective interaction with other departments (internal and external). In particular, close contact maintained with the Microbiology, Production, Validation, Manufacturing and Planning Departments, & QA
- Actively contribute to continuous improvement initiatives in the lab
- QC Micro representation at cross-functional meetings
- Providing audit support
- Conduct duties in a safe manner and report all safety issues or concerns
Sterility Assurance Vaccine Project
