Il y a 44 joursSANOFI AVENTIS GROUPE

TECHNICAL MANAGER QUALITY OPERATION STERILITY ASSURANCE CONTAMINATIO...

  • V.I.E.
  • Toronto, Canada
  • Développement informatique

Description de l'offre

Entreprise:
Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people at Sanofi are dedicated to make a difference in patients’ daily life, wherever they live and enable them to enjoy a healthier life.
iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.
PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.
PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide.
Therefore, only applications that are submitted in English will be considered.
At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.
We are looking for a candidate for a VIE mission of:
Technical Manager Quality Operation Sterility Assurance Contamination Control
- VIE Contract (W/M)
During your VIE assignment you will:
Manage the contamination control program (60%)
Provide oversight and technical direction to ensure the environmental monitoring program along with the cleaning and disinfection regime are executed in accordance with company standards and regulatory requirements:
- Review and approve contamination control related documents (include but are not limited to Standard Operating Procedures, validation / support study protocols / reports, and technical documents such as drawings and specifications)
- Perform routine review of environmental data with the support staff and management (plus issuance of environmental certificates for batch release)
- Make improvements, where necessary, to ensure robust monitoring processes (i.e. efficient, effective, and compliant)
- Perform periodic shop floor surveillance
- Provide Quality direction and approvals to assure environmental conditions and sterile assurance practices for manufacturing are in a state of control
- Assess contamination control related Change Control Requests
Provide leadership to ensure robust investigation of environmental excursions and incidents:
- Assure the investigation is timely, thorough, scientifically sound, and supported with relevant documentation
- Perform risk assessment, data / trend analysis, when required
- Assure corrective and/or preventive actions are adequate and appropriate (aim to reduce future occurrence of environmental excursions / deviations / events
- Review and approve the environmental investigation reports
- Prepare and/or present findings and recommendations to upper management for review and approvals, when required
- Provide technical training on contamination control, when required
- Participate, as Quality representative, on facility / environmental related projects
Support inspection readiness activities (20%)
- Assure the contamination control program is in a state of compliant and inspection ready
- Prepare inspection readiness packages
- Defend the contamination control program during internal and external inspections
- Participate in responding to audit observations and implement corrective action(s) in a timely manner
- Support continuous improvement to the sterility assurance program (20%)
- Participate in sterility assurance improvement projects
- Establish specifications and/or prepare related study protocols and reports, when required
- Develop, revise, review and/or approve sterility assurance related policies and procedures
Requirements:
- Master Degree in Science in Microbiology or Applied Pharmaceutical Sciences / Engineering
- Minimum 1 year of work experience in Good Manufacturing Practices regulated industry with direct contamination control experience (include heating, ventilation, and air conditioning (HVAC) systems, quality design and validation of cleanroom, cleaning and disinfection)
- Sound knowledge on sterile drug manufacturing (e.g. fermentation and aseptic filling, various methods of sterilization, and various types of aseptic applications such as Restricted-access barrier systems (RABS) and isolator technologies)
- Proficient in computing (include MSWord, Excel, PowerPoint, Visio, etc.) and in performing risk and trend analysis
- Team player with good communication skills
- Fluent English both written and verbal